Wednesday, November 2, 2011

Abstract: Meibum lipid composition in asians with DED

Meibum lipid composition in asians with dry eye disease.

BACKGROUND:
Previous lipidomic analyses of the human meibum had largely focused on individuals from non-Asian populations, despite the higher prevalence of dysfunctional tear syndrome (DTS) observed across Asia. Information pertaining to the alterations in lipid profiles in relation to DTS onset and progression is also lacking and warrants comprehensive experimental analysis. METHODOLOGIES/

PRINCIPAL FINDINGS:
We examined the meibum lipidome of 27 DTS patients and 10 control subjects for a total of 256 lipid species from 12 major lipid classes, including cholesteryl ester (CE), wax ester (WE), triacylglyceride (TAG), (O-acyl)-ω-hydroxy fatty acid (OAHFA), glycerophospholipids (phosphatidylcholine, PC; phosphatidylethanolamine, PE; phosphatidylinositol, PI; phosphatidylglycerol, PG) and sphingolipids (sphingomyelin, SM; ceramide, Cer; glucosylceramide, GluCer; dihexosylceramide, DihexCer). Neutral lipids were analysed using high-performance liquid-chromatography coupled with mass spectrometry (HPLC/MS) and tandem mass spectrometry (MS/MS) was used for the qualitative and quantitative analysis of polar lipid species. DTS patients were classified into three severity groups (i.e. mild, moderate and severe) based on the ocular surface disease index (OSDI). A significantly lower level of TAG (p<0.05) was observed in patients under the moderate category compared to the mild category. Notably, a number of OAHFA species displayed consistently decreasing levels that correlate with increasing disease severity. An attempt was also made to investigate the changes in meibum lipid profiles of DTS patients compared to normal individuals classified based on OSDI score. Several unsaturated TAG and PC species were found at significantly higher levels (p<0.05) in patients than controls.

CONCLUSION:
The current study presents, for the first time, a comprehensive lipidome of meibum from individuals of an Asian ethnicity, which can potentially offer new insights into the higher prevalence of DTS observed amongst Asian populations. This study also represents an attempt towards identification of lipid species in meibum which could serve as marker for DTS.


PLoS One. 2011;6(10):e24339. Epub 2011 Oct 17.
Lam SM, Tong L, Yong SS, Li B, Chaurasia SS, Shui G, Wenk MR.
Source
Department of Biological Sciences, National University of Singapore, Singapore, Singapore.

Monday, October 31, 2011

Abstract: Once again, dry eye gets short shrift in LASIK studies

I guess I'm on the warpath this morning.

Refractive surgery research at its best.

This abstract...

1) Purports to assess dry eye amongst its outcome measures (after all, it's the #1 complication so they'd better pay it lip service)
2) Then it uses the most unreliable not to mention barbaric method to evaluate dry eye (Schirmer)
3) Then it doesn't tell us what the dry eye results were, because naturally, only vision matters.

Come on guys, surely you can do better than this.

A prospective, randomized, fellow eye comparison of WaveLight Allegretto Wave Eye-Q versus VISX CustomVue™ STAR S4 IR™ in laser in situ keratomileusis (LASIK): analysis of visual outcomes and higher order aberrations.

PURPOSE:
To compare outcomes in visual acuity, refractive error, higher-order aberrations (HOAs), contrast sensitivity, and dry eye in patients undergoing laser in situ keratomileusis (LASIK) using wavefront (WF) guided VISX CustomVue and WF optimized WaveLight Allegretto platforms.

METHODS:
In this randomized, prospective, single-masked, fellow eye study, LASIK was performed on 44 eyes (22 patients), with one eye randomized to WaveLight Allegretto, and the fellow eye receiving VISX CustomVue. Postoperative outcome measures at 3 months included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refractive error, root-mean-square (RMS) value of total and grouped HOAs, contrast sensitivity, and Schirmers testing.

RESULTS:
Mean values for UDVA (logMAR) were -0.067 ± 0.087 and -0.073 ± 0.092 in the WF optimized and WF guided groups, respectively (P = 0.909). UDVA of 20/20 or better was achieved in 91% of eyes undergoing LASIK with both lasers while UDVA of 20/15 or better was achieved in 64% of eyes using the Allegretto platform, and 59% of eyes using VISX CustomVue (P = 1.000). In the WF optimized group, total HOA increased 4% (P = 0.012), coma increased 11% (P = 0.065), and spherical aberration increased 19% (P = 0.214), while trefoil decreased 5% (P = 0.490). In the WF guided group, total HOA RMS decreased 9% (P = 0.126), coma decreased 18% (P = 0.144), spherical aberration decreased 27% (P = 0.713) and trefoil decreased 19% (P = 0.660). One patient lost one line of CDVA secondary to residual irregular astigmatism.

CONCLUSION:
Both the WaveLight Allegretto and the VISX CustomVue platforms had equal visual and safety outcomes. Most wavefront optimized HOA values trended upward, with a statistically significant increase in total HOA RMS. Eyes treated with the WF guided platform showed a decreasing trend in HOA values.


Clin Ophthalmol. 2011;5:1339-47. Epub 2011 Sep 20.
Moshirfar M, Betts BS, Churgin DS, Hsu M, Neuffer M, Sikder S, Church D, Mifflin MD.
Source
John A Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah, Salt Lake City, UT, USA.

Abstract: Video TFBUT method versus classic method

This is an interesting discussion of ways to capture TBUT.

Measurement of ocular surface protection under natural blink conditions.

PURPOSE:
To evaluate a new method of measuring ocular exposure in the context of a natural blink pattern through analysis of the variables tear film breakup time (TFBUT), interblink interval (IBI), and tear film breakup area (BUA).

METHODS:
The traditional methodology (Forced-Stare [FS]) measures TFBUT and IBI separately. TFBUT is measured under forced-stare conditions by an examiner using a stopwatch, while IBI is measured as the subject watches television. The new methodology (video capture manual analysis [VCMA]) involves retrospective analysis of video data of fluorescein-stained eyes taken through a slit lamp while the subject watches television, and provides TFBUT and BUA for each IBI during the 1-minute video under natural blink conditions. The FS and VCMA methods were directly compared in the same set of dry-eye subjects. The VCMA method was evaluated for the ability to discriminate between dry-eye subjects and normal subjects. The VCMA method was further evaluated in the dry eye subjects for the ability to detect a treatment effect before, and 10 minutes after, bilateral instillation of an artificial tear solution.

RESULTS:
Ten normal subjects and 17 dry-eye subjects were studied. In the dry-eye subjects, the two methods differed with respect to mean TFBUTs (5.82 seconds, FS; 3.98 seconds, VCMA; P = 0.002). The FS variables alone (TFBUT, IBI) were not able to successfully distinguish between the dry-eye and normal subjects, whereas the additional VCMA variables, both derived and observed (BUA, BUA/IBI, breakup rate), were able to successfully distinguish between the dry-eye and normal subjects in a statistically significant fashion. TFBUT (P = 0.034) and BUA/IBI (P = 0.001) were able to distinguish the treatment effect of artificial tears in dry-eye subjects.

CONCLUSION:
The VCMA methodology provides a clinically relevant analysis of tear film stability measured in the context of a natural blink pattern.


Clin Ophthalmol. 2011;5:1349-57. Epub 2011 Sep 22.
Abelson R, Lane KJ, Angjeli E, Johnston P, Ousler G, Montgomery D.
Source
Arizona State University, Tempe, AZ, USA.

A Monday morning rant on LASIK, ARSC and dry eye

The American Refractive Surgery Council Discusses How Advances in LASIK Open Door for Those Once Ineligible

DALLAS, TX -- (Marketwire) -- 10/28/11 -- LASIK was once off-limits to people with thin corneas, dry eye and prescriptions in higher ranges. But thanks to advances in technology and technique, many of those once ineligible for LASIK may now benefit from the popular vision correction procedure....


LAsik,LAsik, RAH RAH RAH!

Classic propaganda on a Monday morning, before I've even had my first cup of coffee. Oops (slap) I forgot, back to green tea.

Fifteen plus years into LASIK, when we've had all this time to study what is well known to be its #1 long-term complication (dry eye), who gets it worst and why... you'd think we would acquire this knowledge and use it to narrow the candidate pool so as to exclude those at highest risk.

Nope. Been there, done that - after all, we kinda-sorta agreed years ago not to push symptomatic people with Sjogrens or RA into LASIK, and to offer PRK instead to a few other people that we think might be high risk, right? That oughta shut up the naysayers.

And we know people everywhere with dry eye are pining to get LASIK, and we want to serve the public well, right? So this is no time to be cautious! It's time to EXPAND the candidate pool. Those fancy new dry eye tests can all be used as part of a bold new marketing plan to show how much you care by identifying people with pre-existing dry eye , explaining how great your technology is at not inducing dry eye, and plying them with steroids and Restasis for awhile before surgery.

Viola. Dry eye? No problem. You Too can benefit from the delights of LASIK! After all, my fancy schmancy femtosecond laser is the latest and greatest and Studies Have Shown* that those don't create as much dry eye as microkeratomes.

Come on guys. You are so blooming predictable. LASIK revenues plummet in an economy like this, and everyone gets more aggressive with the marketing - at what cost?

*well okay maybe not this one.

Friday, October 28, 2011

Abstract: Pollution and the tear film

Can air pollution affect tear film stability? A cross-sectional study in the aftermath of an explosion accident.

BACKGROUND:
After an explosion and fire in two tanks containing contaminated oil and sulphur products in a Norwegian industrial harbour in 2007, the surrounding area was polluted. This caused an intense smell, lasting until the waste was removed two years later. The present study reports examinations of tear film break up time among the population. The examinations were carried out because many of the people in the area complained of sore eyes. The purpose of the study was to assess the relationship between living or working close to the polluted area and tear film stability one and a half years after the explosion.

METHODS:
All persons working or living in an area less than six kilometres from the explosion site were invited to take part in the study together with a similar number of persons matched for age and gender living more than 20 kilometres away. Three groups were established: workers in the explosion area and inhabitants near the explosion area (but not working there) were considered to have been exposed, and inhabitants far away (who did not work in the explosion area) were considered to be unexposed. A total of 734 people were examined, and the response rate was 76 percent. Tear film stability was studied by assessing non-invasive break-up time (NIBUT) using ocular microscopy. In addition Self-reported Break Up Time (SBUT) was assessed by recording the time the subject could keep his or hers eyes open without blinking when watching a fixed point on a wall. Background information was obtained using a questionnaire. Non-parametric Wilcoxon-Mann-Whitney-tests with exact p-values and multiple logistic regression analyses were performed.

RESULTS:
Both NIBUT and SBUT were shorter among the male exposed workers than among the inhabitants both near and far away from the explosion area. This was also found for SBUT among males in a multiple logistic regression analysis, adjusting for age and smoking.

CONCLUSIONS:
Reduced tear film stability was found among workers in an area where an explosion accident had occurred.


BMC Public Health. 2011 Apr 14;11:235.
Moen BE, Norbäck D, Wieslander G, Bakke JV, Magerøy N, Granslo JT, Irgens A, Bråtveit M, Hollund BE, Aasen T.
Source
Occupational and Environmental Medicine, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway. bente.moen@isf.uib.no

Abstract: Rheumatoid arthritis and dry eye

[Ocular involvement and its' manifestations in rheumatoid arthritis patients].
[Article in Hebrew]

PURPOSE:
To study the type, occurrence and nature of ocular involvement amongst patients with rheumatoid arthritis (RA), and to identify demographic, clinical and/or laboratory variables associated with eye involvement in RA. RESEARCH TYPE: Cross sectional research, retrospective

METHODS:
The research was conducted among 61 patients diagnosed with rheumatoid arthritis. The subjects were recruited for the research during their periodic visits to the Soroka Hospital Rheumatology Clinic. Comprehensive rheumatologic tests were administered and general health was examined with a prepared questionnaire. Additionally, the subjects' personal files were examined with data collected from general serum rheumatologic tests and details regarding medications administered. The patients were given a comprehensive eye examination, including a visual acuity examination, test for anterior and posterior fragments, a slit lamp examination after pupil dilation, for epithelial cell filaments, tests for dry eye symptoms, including a Schirmer's test, a tear breakup time test, and a corneal examination for epithelial cells and the existence of superficial punctate keratopathy. The subjects were also questioned regarding their dry eye syndrome and a specular microscopy test was performed. The assembled data was processed and analyzed with the aim of finding correlations between the subjective and objective sensations of dry eye symptoms and the activity of rheumatoid arthritis disease, blood tests, medications taken, and the patient's general state of health.

RESULTS:
The majority of the research subjects (90.2%) were women. Their average age was 51.9 +/- 13.21 years; 31.1% of the subjects complained of eye dryness and, during the eye examination, 85% were found to be suffering from dry eye. The study found a correlation between the objective indicators of keratitis sicca and the following parameters: laboratory values for SGOT (p < 0.03), ESR (p < 0.05), Cr (p < 0.05), TG (p < 0.03), LDL (p < 0.02), Hb (p < 0.01), ALP (p < 0.01), in addition to prednisone medication (p < 0.03, df = 2, x2 = 7.02) and methotrexate (p < 0.03, df = 2, x2 = 8.88). No correlation was found with the following parameters: age, disease duration, smoking, disease severity, other background diseases, and additional laboratory findings including RF and ANA measurements, and consuming other anti-rheumatoid arthritis medications. Similarly, no relation was found with the patients' various subjective syndromes. The average results of the specular microscopy test were 2116.15 +/- 416.59 for the right eye and 2125.67 +/- 446.14 for the left eye.

CONCLUSIONS:
The significance of the specular microscopy test results is that corneal damage found in rheumatoid arthritis patients occurs only to the external layer and does not affect the endothelial layer. The study indicates that keratitis sicca is prevalent among rheumatoid arthritis patients and must be taken into account regardless of the degree that the disease has progressed, because the severity of the dryness is not dependent on disease progression. Additionally, a discrepancy exists between the patients' subjective sensation of their eye condition and the objective findings of the study.


Harefuah. 2011 Sep;150(9):713-8, 751.
Markovitz E, Perry ZH, Tsumi E, Abu-Shakra M.
Source
Department of Ophthalmology, Shaare-Zedek Medical Center, Ben-Gurion.

Wednesday, October 26, 2011

Abstract: Systemic drugs and dry eye

Non-hormonal Systemic Medications and Dry Eye.

Many drugs used for chronic illnesses can contribute to dry eye syndrome, and elderly patients who have dry eye may concurrently be on systemic medications that worsen the condition. Such medications include anticholinergic drugs, eg, antidepressant, antipsychotic, anti-Parkinson's disease, and antihistamine drugs. Other drugs such as anti-acne preparations and antihypertensives can also cause dry eye. In some cases, the adverse effects of the drug on dry eye is dose-related and can be relieved by reducing the dosage. Alternatively, a different drug within the same drug family may alleviate the dry eye problem. Awareness of the drugs that contribute to dry eye will allow ophthalmologists and other physicians to better manage patients who have this common problem.

Ocul Surf. 2011 Oct;9(4):212-26.
Wong J, Lan W, Ong LM, Tong L.
Source
From the Department of Ophthalmology, Tan Tock Seng Hospital.

Abstract: Osmolality and tear film dynamics

Osmolality and tear film dynamics.

The tear film is a nourishing, lubricating and protecting layer that bathes the ocular surface. It is continuously replenished through cycles of production and elimination via evaporation, absorption and drainage. These processes are often referred to as tear film dynamics. Osmolality is an objective clinical measurement that provides insight into the balance of these complex tear film dynamics. Balanced tear production and elimination is vital for tear film integrity, stability and normal osmolality. Imbalances cause alterations of the tear film structure and composition, ultimately leading to tear film instability and measurable tear film hyperosmolality. Elevated tear film osmolality is considered a core mechanism in dry eye, forming the basis of dry eye symptoms and leading to ocular surface damage. Despite its immense potential in the diagnosis of dry eye, tear film osmolality is not commonly assessed. This review will focus on the current knowledge of tear film dynamics and tear film osmolality.


Clin Exp Optom. 2011 Oct 25. doi: 10.1111/j.1444-0938.2011.00634.x. [Epub ahead of print]
Stahl U, Willcox M, Stapleton F.
Source
Vision Cooperative Research Centre, Sydney, Australia School of Optometry and Vision Sciences, University of New South Wales, Sydney, Australia Institute for Eye Research, Sydney, Australia. E-mail: u.stahl@unsw.edu.au.

Abstract: Looking at MGs of GvHD patients with a confocal

Morphologic evaluation of meibomian glands in chronic graft-versus-host disease using in vivo laser confocal microscopy.

PURPOSE:
To evaluate the morphological changes of the meibomian glands (MGs) using in vivo laser confocal microscopy (CM) in dry eye (DE) patients with chronic graft-versus-host disease (cGVHD).

METHODS:
Seventeen eyes from 9 patients with a diagnosis of DE associated with cGVHD (DE/cGVHD group; 6 males, 3 females; median 50.5 years) and 16 eyes of 8 hematopoietic stem cell transplantation (HSCT) recipients without DE (non-DE/non-cGVHD group; 5 males, 3 females; median 47.0 years) were enrolled. CM was used to investigate the MG and MG acinar unit density (MGAUD), MG acinar longest diameter (MGALD), MG acinar shortest diameter (MGASD), and the fibrosis grade. Clinical findings of the lid margin were obtained. Tear dynamics, ocular surface vital staining, meibography, and MG expressibility were also examined. Data were compared between the 2 groups using the unpaired t and Mann-Whitney tests.

RESULTS:
The mean MGAUD value was significantly lower in the DE/cGVHD group than in the non-DE/non-cGVHD group (p=0.01, 57.8±38.3 glands/mm(2), 88.8±26.6 glands/mm(2), respectively), and the mean MGALD and MGASD were significantly shorter in the DE/cGVHD group than in the non-DE/non-cGVHD group (p=0.0018, 37.3±24.4 μm and 60.4±11.8 μm, p=0.0106, 17.7±11.8 μm and 26.6±6.03 μm, respectively). The mean fibrosis grade was significantly higher in the DE/cGVHD group than the non-DE/non-cGVHD group (p<0.0001, 1.39±0.71 grade, 0.06±0.25 grade, respectively). Clinical findings in the lid margin, tear dynamics, and ocular surface findings were significantly worse in the DE/cGVHD group than in the non-DE/non-cGVHD group.

CONCLUSIONS:
CM clearly depicted the morphological changes of the MG in the DE/cGVHD group, and revealed the severity of the meibomian gland dysfunction. Patients with severe DE after HSCT showed atrophic MG and excessive fibrosis.


Mol Vis. 2011;17:2533-43. Epub 2011 Sep 29.
Ban Y, Ogawa Y, Ibrahim OM, Tatematsu Y, Kamoi M, Uchino M, Yaguchi S, Dogru M, Tsubota K.

Abstract: The use of punctal plugs in children

The use of punctal plugs in children.

Background/aims
To evaluate the safety and efficacy of punctal plugs in children with dry eye syndrome.

Methods
A retrospective case series of patients who had an insertion of silicone punctal plugs for dry eye syndrome. Data collected included presenting symptoms, signs, systemic disorders if present, type of anaesthesia and complications by the time of last follow-up.

Results
Twenty-five patients (median age at insertion 7 years, range 1.5-13.8 years) were identified. Median follow-up was 18 months. The commonest symptoms were photophobia, soreness and blepharospasm, and the commonest sign was punctate epithelial erosions. Concurrent systemic disease was present in 18/25 patients. Repeated procedures were carried out in eight of 25 patients. Twenty-four of 35 insertions were performed under general anaesthesia. A substantial improvement in ocular surface disease was noted in all cases: frequency of lubricant use was reduced in eight of 25 and visual acuity improved in 15/25 patients. Spontaneous extrusion was the commonest complication and occurred within 6 months in 19% of cases.

Conclusion
Dry eye syndrome in children is often accompanied by systemic disease, so in a child with persistent symptoms this should be explored. Punctal plugs offer a safe and effective form of treatment especially as compliance of frequent lubrication is limited in children.


Br J Ophthalmol. 2011 Oct 22. [Epub ahead of print]
Mataftsi A, Subbu RG, Jones S, Nischal KK.
Source
Great Ormond St Hospital for Children, London, UK.

Monday, October 24, 2011

Abstract: Plasma rich in growth factors

Important topic... have been hearing from more patients recently pursuing these alternatives to classic autologous serum.

Efficacy of Plasma Rich in Growth Factors for the Treatment of Dry Eye.
PURPOSE:
To evaluate the efficacy of plasma rich in growth factors (PRGF) for the treatment of moderate/severe dry eye.

METHODS:
PRGF treatment was administered to 16 patients who had moderate/severe dry eye diagnosed and who had not responded previously to other standard treatments. We quantified several growth factors present in the PRGF of each patient and obtained quantitative registers of the symptoms (modified score dry eye questionnaire), both before and after PRGF treatment. We also performed impression cytology to determine the degree of squamous metaplasia before and after PRGF treatment.

RESULTS:
PRGF treatment was associated with a statistically significant improvement in score dry eye questionnaire values (P < 0.001). Results from impression cytology corroborated this improvement, but the reduction in the degree of squamous metaplasia was not statistically significant. In 75% of patients treated with PRGF, no further treatments were required, whereas in the remaining 25% other ocular treatments could be reduced.

CONCLUSIONS:
PRGF led to symptom improvement in patients with moderate/severe dry eye. Surprisingly, the symptoms recorded in the dry eye questionnaire do not always agree with the degree of squamous metaplasia measured by impression cytology.


Cornea. 2011 Oct 15. [Epub ahead of print]
López-Plandolit S, Dsci MC, Freire V, Grau AE, Durán JA.
Source
From the Instituto Clínico-Quirúrgico de Oftalmología, Bilbao, Vizcaya, Spain.

Monday, October 17, 2011

Abstract: Topical Epigallocatechin Gallate (from green tea)

This is early stage mice research so don't get excited yet. Interesting stuff, though, & seems to have been studied extensively in the role of skin cancer prevention. In this study it reduced clinical signs and inflammation.

Therapeutic Efficacy of Topical Epigallocatechin Gallate in Murine Dry Eye.

OBJECTIVE:
To study the efficacy of topical epigallocatechin gallate (EGCG) for the treatment of dry eye disease (DED).

METHODS:
Seven- to 8-week-old female C57BL/6 mice were housed in the controlled environment chamber to induce DED. Topical 0.01% or 0.1% EGCG, or vehicle, was applied to the eyes of DED mice. Corneal fluorescein staining and the number of corneal CD11b+ cells were assessed in the different groups. Expression of interleukin-1β, tumor necrosis factor-α, chemokine ligand 2, and vascular endothelial growth factor (VEGF)-A/C/D was evaluated by real-time polymerase chain reaction in the corneas at day 9. Corneas were stained for lymphatic vessel endothelial hyaluronan receptor (LYVE)-1 to evaluate lymphangiogenesis, and the terminal transferase dUTP nick end labeling (TUNEL) assay was used to evaluate apoptosis of corneal epithelial cells.

RESULTS:
Treatment with 0.1% EGCG showed a significant decrease in corneal fluorescein staining compared with the vehicle (24.6%, P = 0.001) and untreated controls (41.9%, P < 0.001). A significant decrease in the number of CD11b+ cells was observed in 0.1% EGCG-treated eyes, compared with the vehicle in the peripheral (23.3%, P = 0.001) and central (26.1%, P = 0.009) corneas. Treatment with 0.1% EGCG was associated with a significant decrease in the corneal expression of interleukin-1β (P = 0.029) and chemokine ligand 2 (P = 0.001) compared with the vehicle and in VEGF-A and VEGF-D levels compared with the untreated group (P = 0.007 and P = 0.048, respectively). EGCG 0.01% also showed a decrease in inflammation at the molecular level but no significant changes in the clinical signs of DED. No cellular toxicity to the corneal epithelium was observed with 0.01% or 0.1% EGCG.

CONCLUSIONS:
Topical EGCG treatment is able to reduce the clinical signs and inflammatory changes in DED by suppressing the inflammatory cytokine expression and infiltration of CD11b+ cells in the cornea.


Cornea. 2011 Oct 11. [Epub ahead of print]
Lee HS, Chauhan SK, Okanobo A, Nallasamy N, Dana R.
Source
From the Schepens Eye Research Institute, and Massachusetts Eye and Ear Infirmary; and Department of Ophthalmology, Harvard Medical School, Boston, MA.

NC center first to offer Lipiflow

I have really mixed feelings about Lipiflow. I love seeing the new innovations springing and at the same time I always seem to find myself gritting my teeth.

More effective than other methods? Probably.
How many patients cannot get sufficient improvement to MGD with other treatments? Dunno.
Pricing? Absolutely scary.
How much symptomatic relief and for how long? Probably all over the map based on what I've heard so far.

If they can make it work financially while using it on people who actually truly need it, great. One of my worries about this sort of thing is that the high-dollar treatments for the most part attract the desperate people who often have quite complex cases whose symptoms are probably not exclusively attributable to blocked MGs.

TearScience Announces First U.S.-Based Eye Care Practice, Carolina Vision Center, to Offer LipiFlow(R) Treatment

MORRISVILLE, N.C., Oct 14, 2011 (BUSINESS WIRE) -- TearScience, Inc., a privately-held medical device company, today announced that Fayetteville, North Carolina-based Carolina Vision Center, is the first eye care center in United States to commercially offer the LipiFlow(R) Thermal Pulsation System, a breakthrough treatment for evaporative dry eye disease. TearScience's LipiFlow is designed to address meibomian gland dysfunction, allowing for the treatment of eyelid gland blockages during a non-invasive procedure administered at an eye care office. Opening the blocked eyelid glands allows the glands to resume the natural production of lipids (oils) needed for a healthy tear film. TearScience received U.S. FDA clearance for its LipiFlow(R) medical device on June 28, 2011.

Abstract: Dry eye symptoms for glaucoma patients

Symptoms and signs of tear film dysfunction in glaucomatous patients.

PURPOSE:
The purposes of this study were to evaluate the presence of symptoms of tear film dysfunction by using the Ocular Surface Disease Index (OSDI) questionnaire in glaucomatous patients and to examine whether they have ocular surface signs.

METHODS:
Fifty patients with ocular hypertension or open-angle glaucoma were sequentially examined. All patients used preserved antiglaucomatous drops once, twice, 3 times, or 4 times a day. Each patient filled out an OSDI questionnaire. Fluorescein corneal staining, lissamine green conjunctival staining, break-up time, and Schirmer I test were performed in patients with positive OSDI.

RESULTS:
Using the OSDI, 26 of 50 patients (52%) showed at least mild symptoms of tear film dysfunction (score >12); of them, 17 (34%) had severe OSDI (Score >32). Decrease in tear production was seen in only 8 glaucomatous patients. The break-up time was <7 s in 18 patients. Lissamine green conjunctival staining was positive in at least one eye of all the 26 patients, whereas fluorescein corneal staining was positive in at least one eye of 22 patients. A statistically significant (P<0.05) difference was found for lissamine green conjunctival staining between 16 patients using ipotensive drops once or twice a day and 10 patients using drops 3 or 4 times a day. In the group of patients using only β-blocker agents, we found a positive correlation between symptoms and vital staining of the ocular surface.

CONCLUSION:
Fifty-two percent of patients in therapy with preserved antiglaucomatous drops showed symptoms of tear film dysfunction. Signs of ocular surface diseases seemed to be greater in patients under >2 medications. Symptoms correlated to signs only in patients in monotherapy with β-blockers drops.


J Ocul Pharmacol Ther. 2011 Jun;27(3):281-5. Epub 2011 May 10.
Valente C, Iester M, Corsi E, Rolando M.
Source
Clinica Oculistica, Department of Neurosciences, Ophthalmology, and Genetics, University of Genoa, Genoa, Italy. valente81@gmail.com

Friday, October 14, 2011

Drug news: Ista's Remura

Remura East was a washout... what a shame, but at least maybe we'll get yet another OTC out of it.

ISTA Pharmaceuticals Reports Results From the Second of Two Studies in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disease

IRVINE, CA, Oct 13, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA -1.96% today announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA(TM) (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies. In both Phase 3 studies, safety data demonstrated REMURA was well-tolerated, with an adverse event profile similar to placebo and consistent with those observed previously with REMURA in a Phase 2 study and with other prescription dry eye drops. All three formulations were rated by patients as very comfortable.

"For the EAST study, we amended the statistical plan to focus on the subpopulation identified in the WEST study as responders. In the previously announced WEST study, the results showed a statistically significant improvement over placebo in the sign of conjunctival staining, as measured using the Lissamine Green (LG) Staining test, among female patients 51-70 years of age with moderate dry eye disease. However, the EAST study did not show a significant difference from placebo in this subpopulation, which we believe is partly due to the fact that the EAST study enrolled far fewer patients with mild to moderate dry eye disease," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "We will complete a full analysis of the data, but focus our efforts on the potential use of the vehicle as an over-the-counter artificial tear product."

Thursday, October 13, 2011

UK optometry community exhorted to do better in dry eye

I appreciated seeing this little tidbit in opticianonline.net... hopefully more UK optometrists will jump in the bandwagon and embrace dry eye.

OOs urged to update eyelid hygiene advice

Optometrists are doing 'more harm than good' by advising patients to employ home-made treatments such as baby shampoo or bicarb scrubs for lid and lash conditions.

Delegates to Johnson & Johnson's White, Bright and Healthy roadshow heard that OOs should get more involved in the management of dry eye and prescribing therapeutics.

Independent West Country OO Sarah Farrant said eye care professionals should take the initiative. In her presentation on investigation and management of dry eye she said up to 30 per cent of over-50s and half of contact lens wearers would suffer from the condition but: 'GPs can't, and ophthalmologists won't', identify and treat it.

Farrant added that some practices were doing more harm than good by advising patients to use baby shampoo or bicarbonate of soda to wipe lids and lashes. 'Baby shampoo is about as disruptive to the lipid as you can get.' She also cautioned against the use of bicarb describing it as: 'the lesser of two evils'.

OO Peter Frampton, who practises in the North East, said OOs had the equipment and the skills to identify the causes of red eye in practice. He urged delegates to get trained and become prescribers of ocular therapeutic drugs. OOs have the skills to make a difference to patients with red eye and becoming a prescriber would add an extra dimension to their practice and allow them to treat patients without having to constantly refer. 'We have got to do it ourselves or we will be waiting for ever,' he added.

The roadshow also looked at contact lens complications, patient retention and diet and supplementation. They continue in Bristol, November 8 and Manchester, November 10.

Orange County dry eye support group...

The OC support group now has a website! You can always check there for upcoming meeting dates. The next is Friday, november 4.

Tuesday, October 11, 2011

Abstract: Serum plus SiHy lens for PED

Combined Application of Autologous Serum Eye Drops and Silicone Hydrogel Lenses for the Treatment of Persistent Epithelial Defects.

PURPOSE:
We investigated the utility of a combination of autologous serum eye drops and a silicone-hydrogel (SH) lens in the treatment of persistent epithelial defects (PEDs).

METHODS:
Eight patients who had distinct PED conditions were treated with 50% (v/v) autologous serum eye drops in combination with silicone hydrogel contact lenses and prospectively observed.

RESULTS:
The pathogenesis of PEDs included Sjo″gren-type dry eye syndrome, graft-versus-host disease, toxic keratitis, limbal cell deficiency, superior limbic keratoconjunctivitis, and neurotrophic keratitis. The patients had PEDs for 90±81.76 days (range: 30-240 days). Before the initiation of the combined treatment, three patients had already been unsuccessfully treated with SH lenses, and five patients had received serum eye drops alone. The PEDs of the eight eyes healed after a treatment period of 11.8±4.9 days. No visible deposits were noted on the surface of any contact lens.

CONCLUSIONS:
These findings demonstrate that the combination of an SH lens and serum eye drops may be effective in the treatment of intractable PEDs.


Eye Contact Lens. 2011 Oct 6. [Epub ahead of print]
Choi JA, Chung SH.
Source
From the Department of Ophthalmology and Visual Science (J.C.), College of Medicine, The Catholic University of Korea, St. Vincent's Hospital, Suwon, Korea; and Seoul St. Mary's Hospital (S.-H.C.), Seoul, Korea.

Abstract: Comparison of 3 lubricant eye drops

Never heard of Blu Sal and Carnidrop (what country are those things sold in? any comparable drop here?) which makes the study much less interesting. So what I really want to know is... why the heck are these dry eye patients being given BAK containing lubricant drops?

Comparison of Three Lubricant Eye Drop Solutions in Dry Eye Patients.
PURPOSE.:
Lubricant eye drops that restore physiological osmolarity represent a promising strategy for dry eye syndrome as hyperosmolarity plays a central role in this disease. This preliminary study compared three lubricant eye drop solutions with different osmolarities and compositions in subjects with this condition.

METHODS.:
Subjects with dry eye syndrome undergoing treatment with benzalkonium chloride-containing lubricant eye drops were randomized to Carnidrop (n = 9), Optive (n = 9), or Blu Sal (n = 9). Fluorescein break-up time (FBUT) and Ocular Protection Index (OPI) were measured at baseline, 15 min, and 60 min after instillation to evaluate the stability and quality of the tear film.

RESULTS.:
At 15 min, a significant increase in FBUT vs. baseline was reported with Carnidrop (from 2.0 ± 0.8 to 4.8 ± 2.0; p = 0.004) but not in patients who received Optive or Blu Sal. At 60 min, FBUT was significantly increased vs. baseline with Carnidrop (from 2.0 ± 0.8 to 6.0 ± 2.8, p = 0.001) and Optive (from 2.9 ± 2.8 to 4.3 ± 2.9, p = 0.004) but not with Blu Sal. At 15 min, OPI was significantly increased from baseline in only the Carnidrop group (from 0.4 ± 0.2 to 1.0 ± 0.4, p = 0.003). This increase was significantly greater with Carnidrop than with Blu Sal (p = 0.003). At the 60 min evaluation, OPI remained significantly increased from baseline in only the Carnidrop group (p = 0.003).

CONCLUSIONS.:
Carnidrop produces a larger increase in FBUT and OPI than Optive and Blu Sal in subjects with dry eye syndrome over a 1 h period, possibly because of its hypo-osmolarity and high osmolyte (in particular l-carnitine) content. The instillation of compounds that improve the quality and stability of the tear film, which are impaired in dry eye syndrome, could be effective in the treatment of this condition.


Optom Vis Sci. 2011 Oct 6. [Epub ahead of print]
Evangelista M, Pescosolido N, Koverech A, Messano M.
Source
*MD †PhD ‡MSc Department of Aging Science (NP) and Department of Ophthalmology (ME), Faculty of Medicine and Surgery, University of Rome "Sapienza," Rome, Italy, and Sigma Tau Industrie Farmaceutiche Riunite S.P.A, Rome, Italy (AK, MM).

Abstract: Punctal and canalicular anatomy

For savvy patients out there who struggle to find effective complete occlusion (plugged, replugged, cauterized, re-cauterized?) this study is rather interesting:

Punctal and Canalicular Anatomy: Implications for Canalicular Occlusion in Severe Dry Eye.

PURPOSE:
To characterize the microscopic anatomy of the lacrimal punctum and canaliculi in relation to the tarsal plate, muscle of Riolan, and Horner muscle; and to report a novel technique to excise the horizontal canaliculus in severe dry eye patients.

DESIGN:
Observational anatomic study and a retrospective case series.

METHODS:
The microscopic anatomy was studied in 86 eyelids of 25 cadavers (age range: 45-96 years, mean: 79.5 years). Surgery was performed on 18 canaliculi of 7 patients with dry eyes (age range: 37-69 years, mean: 59.9 years). In the microscopic study, 32 eyelids were incised sagittally, 38 eyelids were incised horizontally (1 mm from the eyelid margin), and 16 eyelids were incised parallel to the tarsal plate. All specimens were stained with Masson trichrome. In the surgical group, probe-guided horizontal canalicular excision with incision of the Horner muscle to the lateral edge of the lacrimal caruncle was performed. Both canalicular stumps were cauterized.

RESULTS:
In the microscopic anatomic study, the punctum and the vertical canaliculus were part of the tarsal plate with the muscle of Riolan, whereas the horizontal canaliculus was surrounded by the Horner muscle. In the surgical group, all the operated canaliculi were completely occluded without recanalization 12 months postoperatively. No complications were recorded.

CONCLUSIONS:
Based on microscopic anatomic findings that the lacrimal punctum and the vertical canaliculus are part of the tarsal plate, and that the horizontal canaliculus is surrounded by the Horner muscle, excision of the horizontal canaliculus may be an effective technique to treat patients with severe dry eyes.

Am J Ophthalmol. 2011 Oct 6. [Epub ahead of print]
Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I.
Source
Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan.

Those scary Halloween contacts

Talk about a way to have really scary eyes. Corneal melt, anyone?

Oddly enough this topic once came up on the bulletin board amidst a discussion about the high cost of scleral lenses for dry eye ("What do y'all think of those $100 scleral lenses for halloween that they sell on the web?" Eek.)

A scary look

His Halloween costume made the 15-year-old look like a horror film extra.
Only it happened days after the holiday.
After he wore a pair of novelty contact lenses to a party, the teen developed an open sore on his cornea in one eye. The infection nearly ate through his eye.
The patient was the worst that Montgomery County optometrist Dr. Geoffrey Kaplan has seen, so far, but certainly he wasn't the only one who developed problems from so-called "gray market" contact lens.
Kaplan said he sees maybe a handful of patients a year, usually around Halloween and usually teens and young adults, with the telltale signs of wearing contact lenses bought off the street. Mostly he sees patients with bacterial infections, but in some cases corneal ulcers, a vision-threatening infection.

Friday, October 7, 2011

Device news: Lipiflow gets more money

For those of you waiting for Lipiflow to come to a dr. near you... with a fresh $15million going into the effort it may not be too long.

TearScience lands $15M to bring novel dry eye treatment to market

Medical device company TearScience has secured $15 million in debt financing that the company will use to support a pair of products addressing evaporative dry eye.....TearScience has U.S. Food and Drug Administration clearance on two products for dry eye. LipiView, which allows doctors to view the tear film and diagnose the condition. LipiFlow uses a combination of heat and pressure to treat it. Both diagnosis and treatment can be done in a physician’s office. LipiView was FDA-cleared in 2009. LipiFlow received FDA clearance earlier this year. The company also has marketing certification for the products in Europe.

Abstract: Functional visual acuity and tear function

The relation of functional visual acuity measurement methodology to tear functions and ocular surface status.

PURPOSE:
To investigate the relation of functional visual acuity (FVA) measurements with dry eye test parameters and to compare the testing methods with and without blink suppression and anesthetic instillation.

DESIGN:
A prospective comparative case series.

METHODS:
Thirty right eyes of 30 dry eye patients and 25 right eyes of 25 normal subjects seen at Keio University School of Medicine, Department of Ophthalmology were studied. FVA testing was performed using a FVA measurement system with two different approaches, one in which measurements were made under natural blinking conditions without topical anesthesia (FVA-N) and the other in which the measurements were made under the blink suppression condition with topical anesthetic eye drops (FVA-BS). Tear function examinations, such as the Schirmer test, tear film break-up time, and fluorescein and Rose Bengal vital staining as ocular surface evaluation, were performed.

RESULTS:
The mean logMAR FVA-N scores and logMAR Landolt visual acuity scores were significantly lower in the dry eye subjects than in the healthy controls (p < 0.05), while there were no statistical differences between the logMAR FVA-BS scores of the dry eye subjects and those of the healthy controls. There was a significant correlation between the logMAR Landolt visual acuities and the logMAR FVA-N and logMAR FVA-BS scores. The FVA-N scores correlated significantly with tear quantities, tear stability and, especially, the ocular surface vital staining scores.

CONCLUSIONS:
FVA measurements performed under natural blinking significantly reflected the tear functions and ocular surface status of the eye and would appear to be a reliable method of FVA testing. FVA measurement is also an accurate predictor of dry eye status.


Jpn J Ophthalmol. 2011 Sep;55(5):451-9. Epub 2011 Jun 30.
Kaido M, Ishida R, Dogru M, Tsubota K.
Source
Department of Ophthalmology, Keio University School of Medicine, Shinanomachi 35, Shinnjuku-ku, Tokyo, Japan.

Abstract: Mucous production and cationized gelatin nanoparticles

Obviously very technical topic but we don't see a lot these days about mucin secretagogues so I thought those who follow those developments might like to see this one.

Expression of MUC5AC in Ocular Surface Epithelial Cells Using Cationized Gelatin Nanoparticles.

Decreased production of the mucin MUC5AC in the eye is related to several pathological conditions, including dry eye syndrome. A specific strategy for increasing the ocular levels of MUC5AC is not yet available. Using a plasmid specially designed to encode human MUC5AC, we evaluated the ability of hybrid cationized gelatin nanoparticles (NPs) containing polyanions (chondroitin sulfate or dextran sulfate) to transfect ocular epithelial cells. NPs were developed using the ionic gelation technique and characterized by a small size (< 200 nm), positive zeta potential (+20/+30 mV), and high plasmid association efficiency ( >95%). MUC5AC mRNA and protein were detected in conjunctival cells after in vitro transfection of the NPs. The in vivo administration of the NPs resulted in significantly higher MUC5AC expression in the conjunctiva compared to untreated control and naked plasmid. These results provide a proof-of-concept that these NPs are effective vehicles for gene therapy and candidates for restoring the MUC5AC concentration in the ocular surface.


Mol Pharm. 2011 Oct 3;8(5):1783-8. Epub 2011 Aug 2.
Konat Zorzi G, Contreras-Ruiz L, Párraga JE, López-García A, Romero Bello R, Diebold Y, Seijo B, Sánchez A.
Source
Department of Pharmacy & Pharmaceutical Technology, Faculty of Pharmacy, University of Santiago de Compostela , Campus Sur, 15782, Spain.

Wednesday, October 5, 2011

Abstract: Tears Again Hydrate (with and without Restasis)

This is rather an interesting study and since the full text is available free you can easily review the details. They compared a group who took Tears Again Hydrate (flaxseed and evening primrose oil supplement sold on prescription) for six months with a group who took that AND took Restasis for the last 3 months of the 6 month period. In this study it didn't appear that Restasis added much.

Efficacy of a new prescription-only medical food supplement in alleviating signs and symptoms of dry eye, with or without concomitant cyclosporine A.

PURPOSE:
To evaluate the effect of a new, prescription-only medical food supplement containing omega-3 and omega-6 essential fatty acids on dry eye signs and symptoms, with or without concomitant topical cyclosporine.

METHODS:
A total of 43 subjects were randomized and followed for 6 months. Group 1 (n = 23) was assigned to take two soft geltabs of the medical food supplement by mouth twice daily for 6 months. Group 2 (n = 20) was directed to take the medical food supplement in the same manner, along with topical cyclosporine, instilled twice daily during the last 3 months of the study. Subjects were evaluated at baseline, month 1, month 3, and month 6. Primary outcome measures included tear breakup time (TBUT), conjunctival staining, corneal staining, and change in subjective symptoms.

RESULTS:
Both groups had a statistically significant improvement in TBUT between baseline and month 6. In the food supplement only group, TBUT improved by 0.805 seconds from baseline to month 6. In the supplement/cyclosporine group, TBUT improved by 1.007 seconds from baseline. There was no statistically significant difference in TBUT between the two groups at baseline, month 3, or month 6. There were no significant differences in corneal or conjunctival staining between or within groups. Subjective symptoms were also improved in both groups.

CONCLUSION:
Supplementation with the proper balance of omega-3 and omega-6 essential fatty acids improved TBUT and relieved patient symptoms. The addition of topical cyclosporine did not convey any statistically significant improvement in TBUT beyond that achieved by the supplement.


Clin Ophthalmol. 2011;5:1201-6. Epub 2011 Aug 25.
Jackson MA, Burrell K, Gaddie IB, Richardson SD.
Source
Jacksoneye, Lake Villa, IL, USA.

Monday, October 3, 2011

Abstract: Inflammatory process or no?

This is an interesting study in IOVS looking at inflammatory cytokines in "pure" lipid-deficient dry eye versus aqueous deficient or combo. Their conclusion was that based on the minimal protein quantities in the "pure" lipid deficient cases (i.e. no aqueous deficiency), the disease process is not based on inflammation.

Proinflammatory Cytokine Profiling of Tears from Dry Eye Patients by Means of Antibody Microarrays.
Purpose. In the pathogenesis of keratoconjunctivitis sicca, immune processes are thought to play an important role. However, the exact details of the pathomechanisms are still unknown. In this study, the expression patterns of proinflammatory cytokines in the tears of patients with different subtypes of dry eye were analyzed. Methods. One hundred forty-three subjects subdivided into healthy controls (CTRL, n = 38), patients with aqueous-deficient dry eye (DRYaq, n = 35), patients with changes of the lipid layer (DRYlip, n = 36), and patients with a combination of both (DRYaplip, n = 34) were examined. Expression patterns of proteins (e.g., IL-1β, IL-6, ITNF-α, and IFN-γ) were examined using an advanced antibody microarray approach. Results. Several highly significant differences in the cytokine levels of dry eye patients compared with healthy controls were detected. Patients with DRYaq or those with DRYaplip showed elevated levels for most of the tested proteins. For example, IL-1β was found to be elevated 2.4-fold in DRYaq patients and 2.75-fold in DRYaqlip patients (both P < 8.00E-6). The detected amounts of protein in DRYlip patients and in healthy controls showed only minimal differences (fold increase/decrease for all proteins >1.2; P > 5.00E-1). Conclusions. The similarity between the profiles of healthy controls and DRYlip patients justifies the assumption that the pathomechanism of this dry eye subtype is based on mechanisms other than inflammation, whereas it seems to be the case for DRYaq patients.
FROM: Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7725-7730. Print 2011. Boehm N, Riechardt AI, Wiegand M, Pfeiffer N, Grus FH. Source Experimental Ophthalmology, Department of Ophthalmology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.

Abstract: Dry eye and juvenile rheumatoid arthritis

Relation of dry eye to disease activity in juvenile rheumatoid arthritis.
Purpose.
To study the frequency and severity of dry eye in patients with juvenile rheumatoid arthritis (JRA) and its relation to disease activity.
Patients and Methods.
Evaluation for dry eye was done in 40 patients with juvenile rheumatoid arthritis referred for ocular assessment in the Ophthalmology Clinics, Faculty of Medicine, Ain Shams University. They were 28 girls and 12 boys with age range of 7-12 years. Medical history, clinical examination, and full ophthalmologic evaluation were performed for each patient. The dry eye tests included tear film break-up time, Schirmer-1 test, and corneal fluorescein staining. Dry eye severity grading was used. Twenty healthy, age- and sex-matched children were assessed for dry eye as a control group.
Results.
Thirty patients (75%) showed findings consistent with the diagnosis of dry eye. Twenty patients (50%) showed first-degree dryness, 8 (20%) showed second-degree, and 2 (5%) showed third-degree. The score of dry eye severity was significantly lower in remission compared to disease activity. Multiregression analysis showed the only factor affecting dry eye parameters was the duration of illness.
Conclusions.
Dry eye is a common incident in children with JRA and should be screened for in all patients with this disease. Severity of eye dryness is highly correlated with the disease activity.
Eur J Ophthalmol. 2011 Sep 7. pii: FD250C68-C164-4BCA-8ECD-0F12DCE1E97D. doi: 10.5301/ejo.5000042. [Epub ahead of print]El-Shazly AA, Mohamed AA.SourceDepartment of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo - Egypt.

Friday, September 30, 2011

Abstract: Acupuncture for dry eye, rabbit model

Interesting. I know plenty of people who have had acupuncture for dry eye, with mixed results. I have known some who found it very beneficial, though more often what I'm hearing is that people are finding it good for stress and perhaps improving coping with dry eye through the reduction of stress. If you're interested in this topic, check out acupuncture on DryEyeTalk. Here's an example of a recent discussion.

Efficacy of Acupuncture and Identification of Tear Protein Expression Changes Using iTRAQ Quantitative Proteomics in Rabbits.

Purpose:
To evaluate the effect of acupuncture on rabbit tear secretion and compare the difference in tear protein expression caused by acupuncture.

Materials and Methods:
Ten male New Zealand White rabbits were enrolled in this study. The following acupoints around the left eye, Extra 1 (Taiyang), BL 2 (Zanzhu) and SJ 23 (Sizhukong), were selected for acupuncture therapy. Each rabbit received 10 acupuncture sessions of 30 min, three times per week. A quantity of 50 μl rabbit tear was collected at the pre- and post-acupuncture stage in every subject, respectively. Total protein content analysis, one-dimensional gel electrophoresis and quantitative proteomics analysis (iTRAQ) were performed and the results were compared.

Results:
Generally, the tear protein expression after acupuncture was different from that before acupuncture though to some extent they were similar. The time spent collecting rabbit tear after acupuncture was shorter than that before acupuncture. The total protein content in rabbit tear pre- and post-acupuncture was 7.12 μg/μl versus 11.28 μg/μl, respectively. One-dimensional gel electrophoresis showed that tear proteins collected before acupuncture were substantially different than post-acupuncture proteins. In total, twenty-eight tear proteins were identified by iTRAQ. Associated with acupuncture were six up-regulated proteins (tear lipocalin, α-1-antiproteinase, histidine-rich glycoprotein, hemopexin, Vitamin D-binding protein, α-2-HS-glycoprotein) and five down-regulated proteins (Annexin A1, serum amyloid A-3 protein, Helicase-like transcription factor, 15 kDa protein A, protein S100-A9).

Conclusions:
The rabbit tear protein expression difference caused by acupuncture indicates that acupuncture not only stimulates lacrimal gland secretion function but also induces the quantitative change of some proteins in rabbit tear, which may support a positive effect of acupuncture in the treatment of dry eye.


Curr Eye Res. 2011 Oct;36(10):886-94.
Qiu X, Gong L, Sun X, Guo J, Chodara AM.
Source
Department of Ophthalmology, Eye Ear Nose and Throat Hospital of Fudan University , Shanghai , China.

Abstract: Rasch analysis of OSDI

OSDI is definitely a less than perfect tool, but hey, it's the best we got (if I'm wrong please email me a link to something better) for the time being. We patients must have a scientifically validated way to quantify our symptoms or doctors simply won't take our pain seriously (especially in the absence of dramatic clinical signs). - This is also a big issue in getting drugs FDA approved - how can you prove improvement to both signs and symptoms if you can't quantify symptoms reliably?

Rasch Analysis of the Ocular Surface Disease Index (OSDI).

Purpose:
The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Its reliability and validity has been investigated within the classical test theory framework and, more recently, using Rasch analysis. The purpose of the present analysis was to more completely investigate the functioning of its response category structure, the validity of its three subscales, and the unidimensionality of the latent construct it is intended to assess.

Methods:
Responses to the OSDI from 172 women participating in the Dry Eye in Postmenopause (DEiM) study who had previously been diagnosed with dry eye or reported significant ocular irritation and dryness were analyzed. Response category structure and item fit statistics were evaluated for assessment of model fit. Person separation statistics were used to examine the validity of the subscales. Unidimensionality was assessed by principle component analysis of model residuals.

Results:The recommended five-category response structure resulted in disordered response thresholds. A four category structure resulted in ordered thresholds. Item infit statistics were acceptable for all 12 items. Person separation with this category structure was adequate, with person separation index of 2.16. None of the three subscales demonstrated adequate person separation. PCA showed one other significant factor onto which the three environmental items loaded significantly.

Conclusions:All items demonstrated acceptable fit to the model after collapsing categories to order the response thresholds. The original subscales did not prove valid, and there is some evidence of multidimensionality and poor targeting.


Invest Ophthalmol Vis Sci. 2011 Sep 24. [Epub ahead of print]
Dougherty BE, Nichols JJ, Nichols KK.
Source
The Ohio State University College of Optometry, Columbus, OH.

Abstract: Corneal neuropathic pain and blepharospasm

I really appreciate starting to see things in the pain journals on this topic.

Chronic (neuropathic) corneal pain and blepharospasm: Five case reports.

Pain and focal dystonias have been associated with chronic pain conditions such as complex regional pain syndrome. Corneal pain, frequently known as "dry eye", may be a neuropathic pain condition with abnormalities of the nerve plexus. Here we present 5 case histories of patients with defined corneal pain (with associated neuropathic features) and objective measures of changes in the nerve plexus and associated blepharospasm. A putative relationship between pain and blepharospasm suggests potential involvement of the basal ganglia in both these conditions.


Pain. 2011 Oct;152(10):2427-31. Epub 2011 Jul 12.
Borsook D, Rosenthal P.
Source
Center for Pain and the Brain, McLean Hospital, Massachusetts General Hospital, and Children's Hospital of Boston, Harvard Medical School, Boston, MA, USA.

Wednesday, September 28, 2011

Abstract: Demodex

Clinical and immunological responses in ocular demodecosis.

The purpose of this study was to investigate clinical and immunological responses to Demodex on the ocular surface. Thirteen eyes in 10 patients with Demodex blepharitis and chronic ocular surface disorders were included in this study and treated by lid scrubbing with tea tree oil for the eradication of Demodex. We evaluated ocular surface manifestations and Demodex counts, and analyzed IL-1β, IL-5, IL-7, IL-12, IL-13, IL-17, granulocyte colony-stimulating factor, and macrophage inflammatory protein-1β in tear samples before and after the treatment. All patients exhibited ocular surface manifestations including corneal nodular opacity, peripheral corneal vascularization, refractory corneal erosion and infiltration, or chronic conjunctival inflammatory signs before treatment. After treatment, Demodex was nearly eradicated, tear concentrations of IL-1β and IL-17 were significantly reduced and substantial clinical improvement was observed in all patients. In conclusion, we believe that Demodex plays an aggravating role in inflammatory ocular surface disorders.


J Korean Med Sci. 2011 Sep;26(9):1231-7. Epub 2011 Sep 1.
Kim JH, Chun YS, Kim JC.
Source
Department of Ophthalmology, College of Medicine, Chung-Ang University Hospital, Seoul, Korea.

Tuesday, September 27, 2011

Opinion: Are some of us murdering our meibomian glands?

I have observed a trend over the past couple of years where for various reasons more people seem to be overdoing eyelid care in hopes of improving chronic MGD. They are applying heat packs twice or more each day; scrubbing and massaging their lids frequently; and attempting to express the glands regularly. I've even observed some of the savviest patients purchasing medical instruments intended for professionals and using them at home to express their glands.

As a longtime proponent of lid hygiene and heat treatment for MGD I have viewed this trend with increasing concern because I fear that inappropriate use, and over-use, of such treatments might delay rather than assist recovery of the meibomian glands. As I so often have over the years, I went to the doctor who first helped me understand dry eye diseases to elucidate this topic for me. What follows is an article that she wrote for DEZ readers in the wake of our discussion about whether some of us may be actually beating our meibomian glands to death. Enjoy, and please let us know what you think in comments here or via email/dryeyetalk/etc.

Expressing the meibomian glands
by Sandra M. Brown, MD - Cabarrus Eye Center, Concord NC

The meibomian glands live in the upper and lower eyelids. There are approximately 15 - 20 glands per lid. The gland openings lie on the edge of the eyelid just inside the eyelash line. The body of the gland is inside the tarsal plate, which is a very thin piece of cartilage that gives the eyelid its defined shape. When your doctor everts your lid (flips it inside out) he is flipping over the tarsal plate.

Although most diagrams of meibomian glands show a hollow tubular structure that looks like a permanently open space, a meibomian gland is more of a potential space. If the gland is empty of meibomian oils, it collapses in on itself. In fact even when the gland is "full" only a very thin film of oils may actually separate the cells lining the walls of the meibomian gland.

Meibomian oils are not squirted onto the surface of the eye. They seep out slowly under the gentle pumping action of eyelid blinking, combined with continuous oil production which pushes oils out onto the eye lid margin when the gland's potential space is fully expanded.

When the eyelid margin becomes inflamed, this inflammation can "cap off" the meibomian gland orifices. There are numerous causes of eyelid margin inflammation that will not be discussed here. If the glands continue to vigorously produce oils, the oils erupt through the sides of the glands and coalesce into a mass commonly referred to as a stye. However in many patients, obstruction of normal oil seepage causes the meibomian gland to decrease production and the oils retained in the gland become thick and degraded.

In the past 2 - 4 years, eye care providers have become more widely aware of the connection between meibomian gland dysfunction and ocular surface symptoms. One simple office test is to lightly press on the glands while the patient is seated at the slit lamp. The examiner is looking for the quantity and quality of oils, how many glands express, how hard s/he has to push to make this happen, and how readily the oils disperse into the tear film. Meibomian oils are quite easy to see at the slit lamp but essentially impossible to see with the naked eye except through elaborate magnification methods.

It is not necessary for 100% of the meibomian glands to function for adequate oils to be secreted into the tear film. Many asymptomatic patients have far fewer than 100% of the glands producing oils at any given time. Lower lid meibomian glands seem to "take a hit" sooner that upper lid glands, so it is important for your doctor to express both upper and lower lids to give your glands an overall function score. Patients with about 80% of their upper lid glands functioning well may have no symptoms even if the lower lid glands are producing almost nothing.

Eye care providers sometimes prescribe meibomian gland self-expression or patients take it upon themselves to "clear out" their glands periodically. Generally the process is to apply heat to liquefy the oils, followed by eyelash cleaning (or sometimes the reverse order) and then gland expression.

A note on hot compresses. The temperature of eyelid skin is slightly below core "body temperature" and meibomian oils become more liquid just a little above core body temperature. So moderate, sustained heat can keep viscous oils thinner. Patients who use very hot compresses that they can tolerate for only 1-2 minutes are going about it the wrong way. Washclothes are ridiculous due to the very rapid cool-down. There is no difference between dry and wet heat from the perspective of the interior of the meibomian gland. A compress that stays "definitely warm" witout being uncomfortable for at least 4 minutes is probably the most effective approach. It is impossible to really "study" the differences between compress methods.

As regards meibomian gland self-expression, there are several problems with this activity.

First, not all meibomian gland problems are due to blockage of the orifices. If the glands are simply under-producing oils (a common problem in peri-menopausal women) pushing on them won't do anything. If the lid margin inflammation is not under control and the orifices are tightly blocked, oils may not express even with hard pressure. So the treatment is not helpful. But secondly, self-expression can be harmful.

Remember that the gland is a potential space containing a small volume of oil. If you express all the oil out of the gland, you have probably expressed several days' worth of "production". You have depleted your supply. When the gland is empty, it collapses in on itself and the cells lining the potential space come into contact with each other without an intervening "oil slick". This allows the cells to adhere to each other. As the gland refills with oil the potential space expands and the cells separate. Repeated expression can lead to the cells permanently adhering, causing obstructions deeper in the gland. This process will be hastened by the microtrauma induced through the mechanical pressure, especially if applied vigorously and often.

I have seen patients who have basically murdered their meibomian glands through excessive self-expression. How do I know? Because the glands in the far nasal and temporal (ear side) areas are harder to reach. It is also more difficult to apply direct firm pressure to the glands in the upper lids than to those in the lower lids. So I see more non-functioning glands in the centers of both lids than the corners, and the lower lids have more non-functioning glands than the upper lids.

When is self-expression helpful? Some patients have mildly occluded orifices or tend to produce oils that don't seep well. They get into a "stagnation" situation. As part of their overall rehabilitation which MUST include efforts to improve oil quality and open the orifices, mild self-expression following a hot compress can be beneficial.

If you are a frequent (more than once per week) or aggressive self-expresser, ask yourself whether you are doing this "philosophically" because it seems like a smart thing to do or whether expressing truly improves your symptoms. If you are expressing several times per day, it is extraordinarily unlikely that you are getting a "useful" amount of oils onto the ocular surface each time. This habit will only increase the microtrauma to the meibomian gland structure.

Meibomian gland self-expression can be useful at certain stages of treatment. It is recommended by eye care providers, including those who specialize in ocular surface disease. It is important to understand that you can overdo it. You should not use self-expression unless instructed to do so by your eye care provider. If you have ocular surface pain and your provider has never expressed your glands, find a different doc.

What if you are a non-producer? Patients whose meibomian glands have ceased production are in a particularly difficult state. Peri- and post-menopausal women are most prone to this condition since meibomian gland function is regulated by androgen hormones. Some women become abruptly dry during pregnancy and don’t recover after pregnancy. Conversely some women have symptoms before pregnancy and actually feel better during pregnancy. We do not have a good understanding of the complex hormonal interplay that affects meibomian gland function. However, if your glands aren't making oils because they aren't receiving "go" signals from hormones or ocular surface nerves, many of the treatments described above will not be effective. Low production can combine with eyelid inflammation to further reduce the quality and quantity of oils reaching the tear film. Certainly related problems such as eyelid inflammation should be addressed. But for patients whose essential problem is markedly reduced production, it is particularly important to leave your meibomian glands alone!

Remember that the purpose of meibomian gland oils is to stabilize the tear film structure and slow evaporation. Barrier methods to slow evaporation (goggles, masks, etc.) are particularly helpful in this circumstance.

What helps meibomian glands and how:

heat - liquifies oils which tend to become more viscous just below body temperature (eyelid skin cooler than core body temp); see comments above about correct hot compress

doxycycline and minocycline, erythromycin - low dose for at least 60 days - acts as an anti-inflammatory which opens the orifices, thins out the oils in some fashion that we don't understand, decreases the bacterial load on the eye lid margins which opens the orifices

TobraDex ointment - anti-inflammatory, decreased bacterial load; intraocular pressure must be followed if used for more than 1 month

Restasis - in my experience anti-inflammatory effects can improve meibomian gland inflammation as well

omega oils - antiinflammatory, antioxidant, 'good ingredient' for oil production

Azasite applied to eye lid margins (topical equivalent of erythromycin) - antibacterial, maybe something else as well? seems to work for some people not others

Monday, September 26, 2011

Abstract: Ocular surface disease treatment algorithm

This is a nice summary of steps involved in treating dry eye.

A practical treatment algorithm for managing ocular surface and tear disorders.

Management of ocular surface irritation and morbidity associated with dry eye has been plagued by the complex interplay of different pathogenic elements and substantial variability of ocular surface deficits in patients. A practical algorithm is proposed to achieve effective management of dry eye. When the eye is open, ocular surface health is governed by a stable tear film that is maintained by neuroanatomic integration via 2 reflexes. Any dysfunctional element in this neuroanatomic integration is potentially pathogenic and creates ocular surface deficits leading to dry eye. In general practice, 5 major dysfunctional elements have been identified: decreased ocular surface sensitivity, aqueous tear deficiency, lipid tear deficiency, delayed tear clearance, and ineffective tear spread. Clinical workup should be individualized to identify all such dysfunctional elements in each patient through history taking, external and slit-lamp examination, and special tests. However, practical management lies in the detection of delayed tear clearance. The following strategies are advised: (1) eliminate all intrinsic inflammatory, infectious, allergic, and toxic insults, especially those associated with delayed tear clearance; (2) correct diseases that impede and interfere with tear spread and capacity; (3) create delayed tear clearance for aqueous tear-deficient dry eye by punctual occlusion; and (4) treat lipid-deficient dry eye after sufficient aqueous tears have been conserved. The aforementioned algorithm ameliorates ocular surface irritation and curtails morbidity in most patients. This algorithm can also be adopted for complex cicatricial ocular surface diseases before managing the remaining deficits resulting from hydrodynamic deficiency.


Cornea. 2011 Oct;30 Suppl 1:S8-S14.
Tseng SC.
Source
From the Ocular Surface Center and Ocular Surface Research & Education Foundation, Miami, FL.

Drugs in development: VGX-100

Early stage research but sounds interesting.

VGX-100 Identified as Potential New Therapy for Dry Eye Disease

MELBOURNE, Australia, Sept. 13, 2011 /PRNewswire via COMTEX/ -- Data published in the scientific journal Archives of Ophthalmology generated by investigators at the Schepens Eye Research Institute led by Harvard University Professor Reza Dana.

VGX-100 significantly reduced inflammation and corneal epitheliopathy in a mouse model of Dry Eye Disease.

Data indicates major potential opportunity for VGX-100 as a therapeutic for Dry Eye Disease.

Circadian Technologies Limited (asx:CIR)(otcqx:CKDXY) announced today the publication of data in the scientific journal Archives of Ophthalmology showing that its lead development molecule VGX-100, a human antibody against the angiogenic and lymphangiogenic molecule VEGF-C, can significantly reduce inflammation and corneal tissue damage associated with Dry Eye Disease (DED). The data indicates a major new therapeutic opportunity for VGX-100 in the DED setting.

The manuscript entitled "Blockade of Prolymphangiogenic Vascular Endothelial Growth Factor C in Dry Eye Disease" Arch Opthamol. Dol:10.1001/archopthamol.2011.266 is accessible via the Archives of Ophthalmology website ( http://archopht.ama-assn.org ).

DED is a complex, immune-mediated disorder of the ocular surface that has multiple causes and affects about 5 million Americans above the age of 50 years. It is estimated that 10% of Australians will suffer from the condition at some point in their lives. DED severely impacts the vision-related quality of life and the symptoms, including persistent dryness, burning, light sensitivity, pain and blurred vision, can be both psychologically and physically debilitating. The current therapeutic options for DED are limited and mostly palliative. Currently, topical cyclosporine-A is the only approved treatment for DED.

The study, which was led by Professor Reza Dana and Dr. Sunali Goyal of the Schepens Eye Research Institute, Harvard Medical School Department of Ophthalmology, showed that administration of VGX-100 was able to significantly reduce inflammation, lymphangiogenesis and corneal damage in a mouse model of DED.

Prof Reza Dana, MD MSc MPH. Claes Dohlman Chair in Ophthalmology, Professor of Ophthalmology, Harvard Medical School, Co-Director of Research at Schepens Eye Research Institute and senior author of the study said: "Dry Eye Disease is suffered by millions of people in the U.S., but current treatments have significant limitations, and effective treatments are not available for many patients. This current study builds on our previous findings demonstrating that VEGF-C, VEGF-D and VEGFR-3 are upregulated in DED corneas, and demonstrates for the first time that an anti-lymphatic effect, caused by the blockade of VEGF-C, has significant beneficial effects in treating the condition. We strongly believe that blocking lymphangiogenic molecules could become a major new paradigm for the treatment of DED."

Mr. Robert Klupacs, CEO of Circadian Technologies, said: "We have always believed that blockade of VEGF-C will have clinical utility in a variety of conditions, in addition to treating solid tumours. This very exciting data generated by our collaborators at Schepens offers significant opportunities for us to leverage our investment in the VGX-100 oncology program and undertake additional preclinical and clinical development activities for VGX-100 in DED, a disease which still remains extremely difficult to treat."

Support groups: Oct 6, Rochester NY, thyroid eye disease

Kudos to Patricia Marino for organizing this. Should be well worth attending... James Aquavella is a superb corneaMD and will be participating.

Flaum Eye Institute Expert to Discuss Thyroid Eye Disease Oct. 6
New support group forms for people with painful ophthalmic condition
A new support group for people with thyroid eye disease – a painful condition resulting from Graves’ disease – will meet at 5:30 p.m. Thursday, Oct. 6, at the Flaum Eye Institute at the University of Rochester Medical Center, 210 Crittenden Blvd. James Aquavella, M.D., cornea surgeon with the Eye Institute, will discuss dry eye related to the disorder and offer tips for relief.

Thyroid eye disease is closely associated with Graves' disease, an autoimmune disorder and the leading cause of hyperthyroidism, or overproduction of the thyroid gland. The eye problems occur when cells from the immune system attack the muscles and other tissue around the eyes, causing inflammation and a build-up of muscle tissue and fat behind the eye socket. As the deposits grow, it causes the eyeballs to bulge. It’s long believed that the late actor Marty Feldman, best known for his role in “Young Frankenstein,” had thyroid eye disease.

The Rochester-area support group is open to anyone with Graves’ disease or thyroid eye disease, as well as their family members. It offers a forum to share concerns, feelings and information, and offers peer support and encouragement to patients to help them cope with their illness. Spouses and caregivers also can gain a better understanding of the disease and how to support their loved ones. Advance registration is requested. Contact Steve Kofron at (585) 275-3977.

Patricia Marino, Ph.D., an organizer of the group, will share her story of diagnosis and treatment. The retired Rochester City Schools lead teacher and specialist/coach was diagnosed Graves’ disease in 2005. Under the care of Flaum Eye Institute Director Steven Feldon, M.D., M.B.A., an international expert in thyroid eye disease research and care, Marino has overcome most of her symptoms and related challenges. She hopes to offer others helpful support and advice as they cope with the illness.

Saturday, September 24, 2011

Dry eye drugs: Regenerx RGN259 completed Phase II

Results expected late October.

More details in news report.

ROCKVILLE, Md., Sep 23, 2011 (BUSINESS WIRE) -- RegeneRx Biopharmaceuticals, Inc. RGRX -3.13% ("the Company" or "RegeneRx") today announced that treatment and follow-up have been completed on 69 patients in the Company's Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial's protocol. After all study data completes the quality control process and data lock it will then undergo statistical analyses. The trial is on schedule for top-line results to be reported in late October.

This double-masked, placebo-controlled clinical trial will evaluate the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops, in patients with dry eye syndrome. Patients received RGN-259 or placebo twice daily for 30 days. Signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and grittiness, among others, was graded periodically during and following the treatment period. The trial is being conducted by Ora Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials. Additional details regarding the Phase 2 trial are available at:

http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin +beta+4&rank=5

Abstract: Mucin gene expression useful in diagnosing DES

I always think this area of DES research is not emphasized enough so it is nice to see this study.

OCULAR MUCIN GENE EXPRESSION LEVELS AS BIOMARKERS FOR THE DIAGNOSIS OF DRY EYE SYNDROME.

Purpose:
To evaluate mRNA levels of the ocular mucins MUC1, MUC2, MUC4, MUC5AC, and MUC7 in conjunctival impression cytology samples from patients with moderate to severe dry eye syndrome (DES) compared with a population of healthy subjects; and to investigate the use of the levels of these mucin genes as biomarkers of DES and subsequently as a potential diagnostic test for DES.

Methods:
This prospective study commenced in the year 2000 and ended in the year 2009. Thirty eight DES patients and 43 age- and gender-matched healthy subjects completed the initial part of the study. Investigations were repeated at a later stage in 16 healthy subjects and 30 DES patients, which were used as external validation data. Conjunctival impression cytology was performed in all subjects to test gene expression of ocular mucin genes MUC1, MUC2, MUC4, MUC5AC and MUC7. Statistical analysis was performed to determine if there was a difference in the levels of mucin gene expression between the two groups of subjects. Sensitivity and specificity of mucin gene expression for the diagnosis of the DES was calculated.

Results:
The expression of MUC1, MUC2, MUC4 and MUC5AC (P<0.0001) were significantly lower in conjunctival epithelium of patients with DES compared to normal subjects. These results were replicated in the external control subject and patient groups. MUC1 expression levels demonstrated the greatest sensitivity (83.3%) and specificity (87.5%) among all genes tested.

Conclusions:
Our data strongly suggest that the expression levels of MUC1 may be used as a diagnostic test in DES for investigational and selective clinical trials.


Invest Ophthalmol Vis Sci. 2011 Sep 19. [Epub ahead of print]
Corrales RM, Narayanan S, Fernández I, Mayo A, Galarreta DJ, Fuentes-Páez G, Chaves FJ, Herreras JM, Calonge M.
Source
CIBER-BBN (Networking Center for Biomedical Research-Biomaterials, Bioengineering, and Nanomedicine) in Valladolid; Carlos III Health Institute, Ministry of Science and Innovation, Spain.

Wednesday, September 21, 2011

Drug news: SAR 1118

Whoopie, we finally have an addition to the Phase III trial drugs!

SARcode Bioscience announced on Sept. 14 that enrollment is underway for a Phase 3 trial of SAR 1118 ophthalmic solution:

First Patient Enrolled in SARcode Bioscience's Pivotal Dry Eye Study of SAR 1118 Ophthalmic Solution

BRISBANE, Calif., Sept. 14, 2011 /PRNewswire via COMTEX/ -- SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.


SAR 1118 is a first-in-class molecule that inhibits T-cell inflammation by blocking the binding of two key cellular surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade. SAR 1118 may be able to reduce inflammation associated with dry eye disease.

The OPUS-1 trial will study the safety and efficacy of SAR 1118 in the treatment of dry eye disease. Approximately 588 patients will be randomized to receive SAR 1118 5.0% ophthalmic solution or placebo twice daily over 12 weeks. The co-primary endpoints of the study are corneal fluorescein staining score and visual-related function score (reading, driving at night, computer use, and watching television) as measured by the Ocular Surface Disease Index (OSDI), a validated instrument designed to assess the impact of dry eye upon vision-related activities. The safety and tolerability of SAR 1118 compared to placebo at 12 weeks will also be evaluated.

Abstract: Dry eye in Japan

Prevalence and Risk Factors of Dry Eye Disease in Japan: Koumi Study.

OBJECTIVE:
To estimate the prevalence and risk factors of dry eye disease (DED) in a rural setting in Japan.

DESIGN:
Cross-sectional study.

PARTICIPANTS:
We included 3294 subjects, aged ≥40 years who were in the residential registry for Koumi town.

INTERVENTION:
Subjects in a rural mountain area, Koumi town, completed questionnaires designed to detect dry eye diagnosis and risk factors.

MAIN OUTCOME MEASURES:
Clinically diagnosed DED was defined as the presence of a previous clinical diagnosis of DED by ophthalmologists or severe symptoms of DED (both dryness and irritation constantly or often). Current symptoms of DED and possible risk factors such as age, gender, educational history, smoking history, alcohol drinking history, height and weight, visual display terminal (VDT) use, and contact lens (CL) wear, and past/current history of certain common systemic diseases were the main outcome measures. We used logistic regression analysis to examine associations between DED and other demographic factors.

RESULTS:
Of the 3294 eligible residents, 2791 residents (85%) completed the questionnaire. The percentage of women with a composite outcome of clinically diagnosed DED or severe symptoms (21.6%; 95% confidence interval [CI], 19.5-23.9) was higher than that of men (12.5%; 95% CI, 10.7-14.5; P<0.001). A low body mass index (BMI; odds ratio [OR], 2.07; 95% CI, 0.98-4.39), CL use (OR, 3.84; 95% CI, 1.46-10.10), and hypertension (HT) (OR, 1.39; 95% CI, 0.94-2.06) were risk factors for DED in men. Use of a VDT (OR, 2.33; 95% CI, 1.12-4.85), CL use (OR, 3.61; 95% CI, 2.13-6.10), and myocardial infarction or angina were the risk factors (OR, 2.64; 95% CI, 1.51-4.62), whereas high BMI was a preventive factor (OR, 0.69; 95% CI, 0.48-1.01) for DED in women.

CONCLUSIONS:
Among a Japanese cohort, DED leading to a clinical diagnosis or severe symptoms is prevalent. Use of CLs was a common dry eye risk factor in both genders. The condition is more prevalent in men with low BMI, HT, and in women with myocardial infarction or angina and VDT use. Relevant measures directed against the modifiable risks may provide a positive impact on public health and quality of life of Japanese.

FINANCIAL DISCLOSURE(S):
The authors have no proprietary or commercial interest in any materials discussed in this article.


Ophthalmology. 2011 Sep 1. [Epub ahead of print]
Uchino M, Nishiwaki Y, Michikawa T, Shirakawa K, Kuwahara E, Yamada M, Dogru M, Schaumberg DA, Kawakita T, Takebayashi T, Tsubota K.
Source
Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan; Ryogoku Eye Clinic, Tokyo, Japan.

Abstract: Non-contact meibography

I kind of like the sound of this. Anything that can truthfully claim to be predictive of dry eye symptoms has something going for it.

Non-contact meibography: Keep it simple but effective.

PURPOSE:
Meibography is reported to be important in Meibomian Gland Dysfunction (MGD) evaluation. Our purpose was to investigate the usefulness of a standard infra-red video security camera in meibography.

METHODS:
Meibographs were taken of the right lower lid of 17 subjects (female 10; age=44.3years ±13.3 SD), randomly selected from the patient pool of Horst Riede GmbH, Weinheim, Germany. Meibomian glands (MG) were photographed by an near adapted infra-red video security camera and extend of MG loss (MGL) was measured by digital image analyzes. Lipid-layer and non-invasive break-up time (NIBUT) was measured by tearscope, dry eye symptoms were evaluated by the Ocular Surface Disease Index (OSDI). Correlations between MGL scores and ocular signs, tearfilm and symptoms were analyzed by Pearsons, differences between gender by U-test. The ability of MGL to predict dry eye symptoms was evaluated by area under the receiver operative characteristic curve (AUC).

RESULTS:
MGL scores were significantly correlated to lipid-layer pattern (r=-0.68, p=0.001) NIBUT (-0.46, 0.032) OSDI (0.89, 0.001) and age (0.61, 0.005). MGL was significantly larger in female (p=0.001). AUC of MGL was 95.8% (p=0.001; sensitivity=88.9%; specificity=87.5%; threshold=32.3%).

CONCLUSIONS:
MGL is a predictive test of dry eye symptoms. The analyzed significant correlation between MGL and tearfilm and dry eye symptoms indicates the usefulness of the non-contact IR meibograph (PNCM).


Cont Lens Anterior Eye. 2011 Aug 30. [Epub ahead of print]
Pult H, Riede-Pult BH.
Source
Optometry and Vision Research, Weinheim, Germany; Contact Lens & Anterior Eye Research Unit, School of Optometry & Vision Sciences, Cardiff University, UK.

Abstract: Contacts and computers (again)

Approximately one gajillion studies have been published to date showing the effects of any one or all of office air, computers and contact lenses for the ocular surface. Occasionally they're even somewhat interesting or informative.

The Impact of Contact Lens Wear and Visual Display Terminal Work on Ocular Surface and Tear Functions in Office Workers.

PURPOSE:
To evaluate the effect of contact lens (CL) wear and visual display terminal (VDT) work on the ocular surface and tear functions.

DESIGN:
Prospective case-control study.

METHODS:
Sixty-nine CL wearers (45 women and 24 men; mean age, 35.2 ± 7.3 years), and 102 age- and sex-matched non-CL wearers were enrolled in the study (66 women and 36 men; mean age, 36.7 ± 7.3 years). Ocular surface and tear function tests, including vital stainings (fluorescein and rose bengal), Schirmer test, tear meniscus height measurement, and tear film break-up time were performed. The subjective symptoms of dry eyes were evaluated using a dry eye symptom questionnaire. The participants were divided into 4 subgroups according to the total time of VDT work in 1 day (VDT work time in 1 day ≥ 4 hours or < 4 hours) and presence of CL wear. Main outcome measures included ocular surface vital staining scores, Schirmer test results, tear film break-up time, tear meniscus height measurement, and symptom questionnaire score.

RESULTS:
CL users and long-term VDT workers showed significantly worse tear meniscus height values than non-CL users and short-term VDT workers (P < .001). The mean visual symptom scores in CL wearers and long-term VDT workers were significantly higher than the other groups (P < .001).

CONCLUSIONS:
Office workers who wore CLs and spent more than 4 hours engaged in VDT work had a lower tear meniscus volume with significant dry eye and visual symptoms triggered by environmental factors.


Am J Ophthalmol. 2011 Aug 24. [Epub ahead of print]
Kojima T, Ibrahim OM, Wakamatsu T, Tsuyama A, Ogawa J, Matsumoto Y, Dogru M, Tsubota K.
Source
Johnson & Johnson Ocular Surface and Visual Optics Department, Keio University School of Medicine, Tokyo, Japan; Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.

Diagnostics: Health Canada approves InflammaDry Detector

RPS Announces Health Canada Approval of RPS InflammaDry Detector™
(August 22, 2011)
Ten-minute test allows clinicians to detect inflammation in the tears of patients with Dry Eye disease


Email PDF Print
Sarasota, FL (PRWEB) August 22, 2011

On August 11, Health Canada granted Rapid Pathogen Screening, Inc. a Medical Device License for the RPS InflammaDry Detector, the first and only rapid, in-office test to detect elevated levels of MMP-9 in tear fluid. Receiving a Medical Device License allows RPS to begin marketing the RPS InflammaDry Detector in Canada, following the product’s recent release in Europe and Asia. RPS anticipates that the RPS InflammaDry Detector will soon be available for sale in Canada through a reputable distribution partner.

Clinical signs of Dry Eye aren’t always directly related to patient complaints, making this disease difficult to diagnose. Additionally, inflammation is often present in Dry Eye patients long before the appearance of clinical signs. Matrix metalloproteinase-9 (MMP-9) is an inflammatory marker that has consistently been shown to be elevated in the tears of patients with Dry Eye disease. Elevated levels of MMP-9 correlate with clinical exam findings and research shows that MMP-9 may be a more sensitive marker than clinical signs when diagnosing Dry Eye. In addition, studies show that the diagnosis and treatment of elevated levels of MMP-9 prior to LASIK surgery may result in improved wound healing and reduced complications.

The RPS InflammaDry Detector requires only a small sample of human tears to detect elevated levels of MMP-9 and provides results in just 10 minutes. Similar to the company’s first product, the presence of a single blue control line indicates a negative test result and the appearance of both a blue control line and a red result line indicate a positive result. This in-office test can be performed on patients that present with signs and symptoms of Dry Eye or as part of pre-operative screening on patients having LASIK or cataract surgery. By using the RPS InflammaDry Detector, clinicians can make an accurate diagnosis and implement an appropriate treatment plan before patients leave the office.

“Receiving a Medical Device License from Health Canada for the RPS InflammaDry Detector is yet another exciting recent accomplishment for RPS,” says Dr. Robert Sambursky, president and chief medical officer of RPS. “Providing clinicians with a rapid and accurate in-office screening test to detect hidden Dry Eye disease will help identify patients that may benefit from perioperative therapy to improve their ocular surface, leading to better surgical and medical patient outcomes.”

The RPS InflammaDry Detector has a clinical sensitivity of 85% and a specificity of 94%. This level of accuracy allows the clinician to make an appropriate diagnosis and an informed treatment decision during the initial office visit. To learn more about the RPS InflammaDry Detector or other RPS products, visit http://www.rpsdetectors.com.