Thursday, March 7, 2013

Abstract: Smart plugs vs punctal plugs.

A study about smart plugs that makes no reference whatsoever to the very serious complications that have presented a clear trend over their ten years on the market. Great, just great.

What this study DOES say however is that in terms of clinical efficacy (without reference to safety) SmartPlugs and ordinary punctal plugs were not noticeably different... rather sounds like the authors are defending SmartPlugs, but really, if they do not outperform other plugs, it just eliminates even more potential rationale for using them at all.

When is the FDA going to do the right thing and withdraw approval for this !@#$ device? When are the doctors treating the complications patients going to demand it? I am sick and tired of seeing people continue to be harmed unnecessarily.

To compare collared silicone punctal plugs to intracanalicular SmartPlugs for the treatment of moderate to severe dry eye.
 Materials and methods:
In this prospective, randomized, single blind, clinical study, 30 patients (60 eyes) who had been diagnosed with moderate to severe dry eye syndrome were enrolled. Study group I (n=30 eyes) received collared silicone punctal plugs and group II (n=30 eyes) received intracanalicular SmartPlugs. Data for the Schirmer I test, tear break-up time, vital staining, subjective symptoms and frequency of artificial tear application were recorded at baseline and 3 months after punctal occlusion.
There was no statistical significant difference for these values between group I and II.
Although published data show free flow with irrigation and probing after SmartPlug insertion, the clinical effect in the treatment of dry eye appears to be the equally well to collared silicone punctal plugs. It seems likely that difference of design and localization between the treatment groups were of minor importance concerning impeding of natural and supplemental moisture.

Curr Eye Res. 2013 Feb 12. [Epub ahead of print]
Rabensteiner DF, Boldin I, Klein A, Horwath-Winter J.
Department of Ophthalmology, Medical University of Graz , Austria.

Abstract: How many blinks could a dry eye blink if....

One of those "Ya think?" studies. :-)

Speaking of which, y'oughtta see my blink rate this time of night while looking at a computer. More frequent than once per second, I guarantee.

Our aim was to extend the concept of blink patterns from average interblink interval (IBI) to other aspects of the distribution of IBI. We hypothesized that this more comprehensive approach would better discriminate between normal and dry eye subjects.
Blinks were captured over 10 minutes for ten normal and ten dry eye subjects while viewing a standardized televised documentary. Fifty-five blinks were analyzed for each of the 20 subjects. Means, standard deviations, and autocorrelation coefficients were calculated utilizing a single random effects model fit to all data points and a diagnostic model was subsequently fit to predict probability of a subject having dry eye based on these parameters.
Mean IBI was 5.97 seconds for normal versus 2.56 seconds for dry eye subjects (ratio: 2.33, P = 0.004). IBI variability was 1.56 times higher in normal subjects (P < 0.001), and the autocorrelation was 1.79 times higher in normal subjects (P = 0.044). With regard to the diagnostic power of these measures, mean IBI was the best dry eye versus normal classifier using receiver operating characteristics (0.85 area under curve (AUC)), followed by the standard deviation (0.75 AUC), and lastly, the autocorrelation (0.63 AUC). All three predictors combined had an AUC of 0.89. Based on this analysis, cutoffs of ≤3.05 seconds for median IBI, and ≤0.73 for the coefficient of variation were chosen to classify dry eye subjects.
(1) IBI was significantly shorter for dry eye patients performing a visual task compared to normals; (2) there was a greater variability of interblink intervals in normal subjects; and (3) these parameters were useful as diagnostic predictors of dry eye disease. The results of this pilot study merit investigation of IBI parameters on a larger scale study in subjects with dry eye and other ocular surface disorders.

Clin Ophthalmol. 2013;7:253-9. doi: 10.2147/OPTH.S39104. Epub 2013 Feb 1.
Johnston PR, Rodriguez J, Lane KJ, Ousler G, Abelson MB.
Ora, Inc, Andover, MA, USA.

Abstract: Effect of pterygium surgery on tear osmolarity

To investigate changes of dry eye test results in patients who underwent pterygium surgery.
Seventy-four patients who underwent primary pterygium surgery were enrolled in this study. At the baseline, 3-, 12-, and 18-month visits, measurements of tear osmolarity, BUT, and Schirmer test were performed. The patients were divided into 2 groups: Group 1, which consisted of patients in whom pterygium did not recur, and Group 2, which consisted of patients in whom pterygium recurred after surgery.
The patients in Group 1 had lower tear osmolarity levels after surgery than those at baseline (all P < 0.001). In Group 2 the tear osmolarity levels did not differ from baseline after 18 months (P = 0.057). The prevalence rates of dry eye syndrome (DES) were lower than that at baseline and 18 months after surgery in Group 1 (P = 0.002). In Group 2, the incidence of DES was lower after 3 months than at baseline (P = 0.03) but was similar to the baseline rate after 12 and 18 months (both P > 0.05).
Anormal tear film function associated with pterygium. Pterygium excision improved tear osmolarity and tear film function. However, tear osmolarity deteriorated again with the recurrence of pterygium.

J Ophthalmol. 2013;2013:863498. doi: 10.1155/2013/863498. Epub 2013 Jan 20.
Türkyılmaz K, Oner V, Sevim MŞ, Kurt A, Sekeryapan B, Durmuş M.
Department of Ophthalmology, Recep Tayyip Erdoğan University Medical School, 53100 Rize, Turkey.

Abstract: Tacrolimus in extreme dry eye cases

To evaluate the therapeutic effects of topical tacrolimus ointment on refractory inflammatory ocular surface diseases.
Retrospective interventional consecutive case series.
In Severance Hospital, Seoul, South Korea, 0.02% tacrolimus ointment was topically applied 1 to 3 times per day, depending on disease severity, for up to 31 months in eyes of 12 consecutive patients with refractory inflammatory ocular surface diseases who had previously been treated with steroid therapy. Seven patients had chronic cicatrizing conjunctivitis (6 cases caused by Stevens-Johnson syndrome and 1 attributable to ocular cicatricial pemphigoid); 4 had scleritis (3 necrotizing scleritis, 1 recurrent nodular scleritis); and 1 patient had Mooren ulcer with corneal perforation. The therapeutic outcomes after tacrolimus treatment were evaluated according to the following criteria: change in clinical findings (eg, decrease of hyperemia, ocular pain, epithelial defect, and pseudomembrane), intraocular pressure (IOP), and need for steroid therapy.
In all 3 groups, tacrolimus showed an immunosuppressive effect, especially on scleritis and Mooren ulcer. These effects included suppression of corneoscleral melting and reduction of hyperemia. In chronic cicatrizing conjunctivitis, simultaneous topical tacrolimus while tapering steroid therapy suppressed inflammatory relapse. The elevated IOP in steroid responders recovered to normal range after successful tapering of steroid. No adverse side effects were noted after 1.5 to 31 months of continuous tacrolimus treatment.
The use of topical tacrolimus ointment is effective in controlling refractory inflammatory ocular surface disease, and can reduce the need for steroid use while reducing inflammation recurrence.

Am J Ophthalmol. 2013 Feb 6. pii: S0002-9394(12)00863-X. doi: 10.1016/j.ajo.2012.12.009. [Epub ahead of print]
Lee YJ, Kim SW, Seo KY.
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea.

Abstract: Clinical characteristics of short TBUT dry eye

[Article in Japanese]

To evaluate the clinical characteristics and management of short tear film breakup time (BUT) -type dry eye.
Clinical background and post-treatment changes of symptoms in 77 patients with short BUT -type dry eye were investigated. Treatment consisted of artificial-tear eye-drop instillation and, if necessary, the addition of a low-density-level steroid, hyaluronic acid, a low-density-level cyclopentolate prepared by ourselves and punctal plugs inserted into the upper and lower lacrimal puncta.
There were three times more women than men among the patients, and the peak age of occurrence was in the twenties in the men and in the sixties in the women. Our findings show that visual display terminal (VDT) work, contact lens (CL) wear, and changes in the sex hormones may initiate subjective symptoms. Some patients had simultaneous conjunctivochalasis, allergic conjunctivitis, and meibomian gland dysfunction. Nineteen patients (24.7%) were effectively treated with eye-drop instillation alone. Thirty-seven patients (48.1%) required punctal-plug insertion, which was completely effective in only 8 of them (21.6%).
Mainly young men and menopausal women contract short BUT -type dry eye. Changes in sex hormones, VDT work and CL wear may be causal, and the disease cannot be controlled by eyedrop and punctal-plug treatment alone.

Nihon Ganka Gakkai Zasshi. 2012 Dec;116(12):1137-43.
Yamamoto Y, Yokoi N, Higashihara H, Inagaki K, Sonomura Y, Komuro A, Kinoshita S.
Department of Ophthalmology, Fukuchiyama City Hospital, Japan.

Abstract: Conjunctivchalasis contributing to OSD in glaucoma patients

To evaluate the impact of conjunctivochalasis (CCh) and its severity on the ocular surface parameters of glaucoma subjects treated with topical antiglaucomatous medication.

One hundred patients with the clinical diagnosis of glaucoma were recruited for this study. CCh was graded based on the extent of inferior lid margin involvement as follows: 1=single (temporal) location, 2=two locations (nasal and temporal), and 3=whole lid. For all the subjects, the break-up time (BUT), lissamine green (LG) staining, and Schirmer test (under topical anesthesia) was performed for both eyes. Ocular Surface Disease Index (OSDI) questionnaire scores were also noted for each subject. Student t test, Mann-Whitney U test, and Kruskal-Wallis test was used for statistical evaluations.

Sixty-three subjects had evidence of CCh; 32 had grade 1, 24 had grade 2, 7 had grade 3 CCh, and 37 glaucoma patients had no evidence of CCh. There were significant differences in the BUT scores (7.2±2.7 vs. 10.1±2.4 s, P < 0.001), Schirmer values (7.7±3.9 vs. 13.3.±4.0 mm, P < 0.001), LG staining score (1.6±1.0 vs. 0.3±0.5, P < 0.001), and the OSDI scores (19.4±17.2 vs. 6.7±5.2, P < 0.001) between patients who had CCh and those without CCh. The BUT scores and Schirmer test values of patients with grades 2 and 3 CCh were significantly lower than those of grade 1 CCh and those without CCh (P < 0.001). The LG grading and OSDI scores were significantly higher in grade 2 and 3 patients as compared with those with grade 1 CCh and those without CCh (P < 0.001).

The functional characteristics of the ocular surface appear to be adversely influenced by the presence and the extent of CCh in glaucoma patients.

J Glaucoma. 2013 Jan 31. [Epub ahead of print]
Kocabeyoglu S, Mocan MC, Irkec M, Orhan M, Karakaya J.
Department of Ophthalmology, Hacettepe University School of Medicine, Ankara, Turkey.

Abstract: Drier + environmental stress = worse allergic reactions

The goal of this study was to assess the effect of a controlled adverse environment (CAE) challenge on subjects with both allergic conjunctivitis and dry eye.
Thirty-three subjects were screened and 17 completed this institutional review board-approved study. Subjects underwent baseline ocular assessments and conjunctival allergen challenge (CAC) on days 0 and 3. Those who met the ocular redness and itching criteria were randomized to receive either the controlled adverse environment (CAE) challenge (group A, n = 9) or no challenge (group B, n = 8) at day 6. Thirty minutes after CAE/no-CAE, subjects were challenged with allergen and their signs and symptoms graded. Exploratory confocal microscopy was carried out in a subset of subjects at hourly intervals for 5 hours post-CAC on days 3 and 6.
Seven minutes post-CAC, subjects exposed to the CAE had significantly greater itching (difference between groups, 0.55 ± 0.25, P = 0.028), conjunctival redness (0.59 ± 0.19, P = 0.002), episcleral redness (0.56 ± 0.19, P = 0.003) and mean overall redness (mean of conjunctival, episcleral, and ciliary redness, 0.59 ± 0.14, P < 0.001). The mean score at 7, 15, and 20 minutes post-CAC for conjunctival redness (0.43 ± 0.17, P = 0.012), episcleral redness (0.49 ± 0.15, P = 0.001), mean overall redness in all regions (0.43 ± 0.15, P = 0.005), and mean chemosis (0.20 ± 0.08, P = 0.017) were also all significantly greater in CAE-treated subjects. Confocal microscopic images of conjunctival vessels after CAC showed more inflammation in CAE-treated subjects.
In subjects with both dry eye and allergic conjunctivitis, exposure to adverse environmental conditions causes an ocular surface perturbation that can intensify allergic reactions.

Clin Ophthalmol. 2013;7:157-65. doi: 10.2147/OPTH.S38732. Epub 2013 Jan 20.
Gomes PJ, Ousler GW, Welch DL, Smith LM, Coderre J, Abelson MB.
Ora Inc, Andover, MA.