Wednesday, August 27, 2008

Public comments to the FDA re: LASIK redacted

According to Dickenson's FDA Review (this is subscription only but you can get a free trial subscription at if you want to read the entire article - it's dated 8/26/2008):

Once labeled one of the most secretive government agencies for consumers, FDA seems to continue to shoot itself in the foot on the “transparency” front. Notwithstanding a regulation at a regulation at 21 CFR 20.103 that says all public comments received by the agency are available for public disclosure, the agency has taken the unprecedented action of redacting the names, affiliations/locations and apparently random slabs of text from all but two of the 246 public comments it received after the 4/25 meeting of its Ophthalmic Devices Panel on LASIK safety.

Why? In an effort to find out, FDA Webview asked panel executive secretary Karen Warburton. She did not respond to two emails. We next asked acting Office of Public Affairs head Judy Leon, who replied: “Since your question deals with FOI process your best bet is to redirect your question to the Freedom of Information office.” So we asked FOI Division director Frederick J. Sadler, who also did not respond.

In addition to redacting all but two commenters’ names, affiliations and addresses, FDA also redacted device names and LASIK surgeons’ names and affiliations from the text of comments, as well as seemingly arbitrary other words and phrases....

For those of you who sent comments to the FDA for that meeting: If you wished and expected that your comments would be published in full, I recommend you contact the FDA and perhaps your congressperson about this.

Monday, August 25, 2008

Abstract: Systane

Varying the pace, a Romanian infomercial :)

[Assessment of systane in severe dry eye]
Oftalmologia. 2008;52(1):105-10.
[Article in Romanian]

Mocanu C, Bărăscu D, Bîrjovanu F, Mănescu R, Iliuşi F.
Clinica de Oftalmologie Craiova.

The study proposes the evaluation of the Systane effect on people that have severe dry eye sensation, with cornea or conjunctive complications. In order to do this, a study protocol has been adopted which meant comparing the values of lacrimal film break-up time, before and after Systane treatment, comparing cornea and conjunctive staining, comparing the crystalization test before and after treatment, comparing the conjunctival impression before and after treatment, and the general acceptability of Systane. The study results have shown that in severe dry eye cases, Systane increases lacrimal film break-up time by 2-3 seconds than the initial value, as well as considerable reduction in corneanl/conjunctival staining and in conjunctival hyperemia in Sicca keratoconjunctivitis. After treatment, conjunctival impression have shown the proliferation of conjunctival and goblet cells, with normal morphologic aspect of the new-formed cells. In every case, the regenerating effect on epithelia of Systane was obvious, which is determined by the direct action of the HP-guar, forming a protective layer with lubricative effect, helpful to the initiation of tisular repairing processes.

Abstract: Dry eye as an occupational hazard

Doesn't look too sophisticated but it would be very interesting to see a more in depth study of this type - not just for airline personnel, either.

[Is dry eye syndrome a profesional disease for aeronautical personnel?]
Oftalmologia. 2008;52(1):100-4.
[Article in Romanian]
Nicodin A, Macri M.

The purpose of this study is to analyze the eye comfort of the aeronautical personnel. This study has been conducted in ophthalmologic office of the National Institute of Aeronautical and Space Medicine, for 68 patients (group 1), men and women, active aeronautical personnel, between 35-55 years old, apparently ophthalmologically normal subjects. First the patients were subjected to a questionnaire that was meant to provide the subjective evaluation as such included: biomicroscopy, fluorescein stain, tear break up time (BUT), Schirmer tear test. There have been found subclinical, mild and moderate dry eye; tear substitutes have been prescribed. The patients were checked up each 3 months, for a period of 9 months. Results were compared with those obtained from a control group--20 people (group 2), women and men, with ages in the same range, people not involved in the aviation field who requested ophthalmological examination for optical correction. The results raise the question: can the "Dry eye syndrome" be considered a work-related disease? The answer will be "probably no" indulging oneself conditions required by International Aeronautical Authority (ex. periodically hydration and enough in volume), even if categorically environment element--conditions inside the aircraft can produce this disorder. During the flight the aeronautical personnel should use tear substitutes, because of the low humidity of the air inside the craft.

Abstract: More on indoor environment and dry eye

Atopy, symptoms and indoor environmental perceptions, tear film stability, nasal patency and lavage biomarkers in university staff.Int Arch Occup Environ Health. 2008 Jul;81(7):861-72. Epub 2007 Dec 8.
Bakke JV, Wieslander G, Norbäck D, Moen BE.

OBJECTIVE: Study associations between airway symptoms, complaints on environmental perceptions, atopy definitions and biomarkers including tear film stability (BUT), nasal patency and nasal lavage (NAL). Personal predictors (gender, age, smoking, infections) for the biomarkers as well as associations between the biomarkers were also assessed.

METHODS: A cross-sectional study of 173 employees in four university buildings, response rate 86%. Tear film break up time (BUT) was measured by a non-invasive method (NIBUT) and self-reported (SBUT). NAL-analysis included eosinophilic cationic protein (ECP), myeloperoxidase (MPO), lysozyme and albumin. Total serum IgE, and specific IgE using Phadiatop was measured. Data on subjective symptoms, environmental perceptions and background data were collected by use of a questionnaire. Multiple regression analyses were applied.

RESULTS: Mean age was 43 years, 21% had weekly ocular, 21% nasal, and 17% laryngeal symptoms. Women had more complaints on environmental perceptions, shorter BUT and less nasal patency. Neither atopy (Phadiatop) nor Total IgE or allergy in the family, but asthma and hay fever was associated with mucosal symptoms or perceptions. Subjects with positive Phadiatop had higher levels of all NAL-biomarkers. Those with ocular symptoms had shorter BUT. Nasal symptoms were related to respiratory infections and laryngeal symptoms to NAL-lysozyme. Perceiving dry air was associated with lower BUT and reduced nasal volume difference before and after decongestion. Older subjects had greater nasal patency, and less atopy. All NAL-biomarkers were positively correlated. Higher lysozyme level was associated with less nasal patency and greater nasal decongestion.

CONCLUSIONS: BUT and NAL-lysozyme was associated with ocular, nasal, laryngeal symptoms and indoor environmental perceptions. Ever having had asthma and ever having had hay fever were predictors for symptoms and perceived air quality, respectively. Phadiatop, Total IgE, familiar allergy and ever eczema were not associated to symptoms or perceived environments. Age, gender and Phadiatop were main predictors for ocular and nasal biomarkers.

Abstract: Computer use & dry eye

Don't think I need to bother commenting on this... it's nothing we don't all already know, sigh, but human resources departments need to see things like this so they will be more willing to accommodate special requirements and work on making a more eye friendly office environment.

Prevalence of Dry Eye Disease among Japanese Visual Display Terminal Users.
Ophthalmology. 2008 Aug 15. [Epub ahead of print]Uchino M, Schaumberg DA, Dogru M, Uchino Y, Fukagawa K, Shimmura S, Satoh T, Takebayashi T, Tsubota K.

OBJECTIVE: To determine the prevalence of dry eye disease (DED) and risk factors among young and middle-aged Japanese office workers using visual display terminals (VDTs).

DESIGN: Cross-sectional prevalence survey.

PARTICIPANTS: Four thousand three hundred ninety-three Japanese young and middle-aged office workers using VDTs.

INTERVENTION: Office workers completed questionnaires sent by e-mail 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 dry eye specialists or severe symptoms of DED (both dryness and irritation constantly or often). Current symptoms of DED and possible risk factors such as age, duration of VDT use, type of VDT work, environmental factors, presence of systemic diseases, systemic medicine use, smoking history, and contact lens (CL) use were the main outcome measures. We used logistic regression to examine associations between DED and other demographic factors.

RESULTS: Of the 4393 office workers, 3549 (80.1%) completed the questionnaire. Clinically diagnosed DED was present in 266 (10.1%) of 2640 male subjects and in 195 (21.5%) of 909 female subjects. Severe symptoms of DED were observed in 711 male and in 436 female participants. More than 4 hours of VDT use was associated with an increased risk of DED (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.40-2.02). In addition, CL use (OR, 3.91; 95% CI, 3.37-4.53) increased the risk of severe dry eye symptoms.

CONCLUSIONS: Dry eye disease leading to a clinical diagnosis or severe symptoms is prevalent among young and middle-aged Japanese office workers. The condition is more prevalent among females, CL wearers, and prolonged VDT users. Relevant measures directed against the modifiable risks could provide a positive impact on public health and quality of life of office workers. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.