The quality of reporting of randomized clinical trials published in Ophthalmology.

PURPOSE: To evaluate the quality of reporting of all the new randomized clinical trials published during 1999 in OPHTHALMOLOGY: using the CONSORT statement parameters. DESIGN: Descriptive series of published studies. STUDIES INCLUDED: Randomized clinical trials. METHODS: Eligible studies were all randomized clinical trials published in Volume 106 (1999) of OPHTHALMOLOGY: that reported the results of prospectively conducted studies in humans comparing two or more therapeutic options with regard to their effect on one or various outcomes, in which the authors stated that a process of randomization or quasi-randomization was performed before the interventions. Each study was evaluated by two independent observers establishing the specific report in the published manuscript of 57 CONSORT statement descriptors, and consensus was obtained between evaluators. MAIN OUTCOME MEASURES: Overall presence of CONSORT statement descriptors in published reports. RESULTS: The mean number of positive CONSORT descriptors for the 24 eligible randomized clinical trials was 33.42 (standard error of the mean [SEM] 1.57) of 57 possible. This score was significantly different (P: < 0.001) from the score of 16.6 (standard error of the mean 0.6) reported for OPHTHALMOLOGY: in the 1991 to 1994 study by Scherer and Crawley. Of the nine descriptors measuring the quality of abstract reporting, a mean of 6.25 (SEM 0.3) was included in the 24 study abstracts evaluated, significantly different from the Scherer and Crawley score (5.2, SEM 0.2. P: < 0.001). Four and six descriptors increased and decreased, respectively, their reporting in more than 20%. Key descriptors such as hypothesis postulation, primary outcome determination, sample size calculations, and a discussion of the limitations of the study such as bias, imprecision, and internal validity are still reported in less than 42% of clinical trials. CONCLUSIONS: This study describes for the first time after the adoption of the CONSORT statement recommendations the status on the quality of reporting of recently published randomized clinical trials in OPHTHALMOLOGY: Although not a direct measure of the intrinsic quality of a study, reporting quality provides the reader with useful tools for the evaluation of its validity. The quality of reporting of randomized clinical trials shows an overall improvement when compared with the period between 1991 and 1994. However, there is still significant room for improvement, especially in descriptors essential for the validation of clinical trial results that are still widely underreported.

The BioMask for treatment of corneal surface irregularities with excimer laser phototherapeutic keratectomy.

PURPOSE: To assess the characteristics of BioMask as a potential masking agent for use with the excimer laser. METHOD: We addressed ablation rate, smoothness, ease of use, dioptric shift, treatment of standardized irregular topography, and ability of BioMask to induce dioptric change in vivo. RESULTS: BioMask ablates at a rate of 0.28 microm per pulse. The BioMask conforms to the base curve of a contact lens in the excimer blank, eye bank eye, and rabbit eye with a r2 of 0.9982, 0.9844, 0.9858, respectively. We are readily able to create 20 diopters of flattening or steepening (r2 = 0.9944). Standardized irregular topography generation in the rabbit eye and then removal with BioMask was successful. The central corneal topography of the rabbit cornea showed predictable changes with various contact lens base curves with the BioMask (r2 = 0.875). CONCLUSIONS: BioMask has excellent potential as an ablatable mask material in the treatment of superficial corneal scars.

Meta-analysis on the recurrence rates after bare sclera resection with and without mitomycin C use and conjunctival autograft placement in surgery for primary pterygium.

BACKGROUND/AIMS: Bare sclera resection with and without use of mitomycin C and conjunctival autograft placement are three surgical techniques currently in use for the treatment of primary pterygium. The purpose of this study was to determine through a meta-analysis the risk for postoperative pterygium recurrence comparing the three surgical treatment modalities. METHODS: A search through Medline for randomised controlled clinical trials comparing at least two of the three surgical techniques in the treatment of primary pterygium, along with a hand search of all references in relevant papers, was conducted. All eligible clinical trials were graded for quality utilising the Detsky score; those studies with a score of 0.5 or greater were included. The main outcome measurements were the pooled odds ratios and 95% confidence intervals for the risk of pterygium recurrence. These were calculated utilising the Mantel-Haenszel method. RESULTS: Five eligible studies with an adequate quality score were retrieved, three comparing bare sclera resection with and without mitomycin C use, one comparing bare sclera resection with conjunctival autograft placement, and one comparing both. The pooled odds ratio for pterygium recurrence in patients who had only bare sclera resection was 6.1 (95% confidence intervals, 1.8 to 18.8) compared with the patients who had conjunctival autograft placement and 25.4 (9.0 to 66.7) compared with the patients who received mitomycin C. CONCLUSIONS: The odds for pterygium recurrence following surgical treatment of primary pterygium are close to six and 25 times higher if no conjunctival autograft placement is performed or if no intra/postoperative mitomycin C is used, respectively. Surgeons and clinical triallists should not be encouraged in the use of bare sclera resection as a surgical technique for primary pterygium.

The epidemiology of diabetes mellitus and diabetic retinopathy.

An apparent epidemic of diabetes is occurring in adults worldwide. This trend seems to be associated with socioeconomic and lifestyle changes. The population of developing countries and some communities within developing countries are at higher risk. Diabetic eye disease and its complications, especially diabetic retinopathy, are a leading cause of blindness and visual dysfunction in adults in economically developed societies. Epidemiological studies of the impact of diabetic eye disease in developing countries are scarce. Risk factors for the development and progression of diabetic retinopathy include, among others, hyperglycemia, genetic factors, race, duration of the disease, arterial hypertension, and proteinuria.

The cornea in diabetes mellitus.

Diabetes mellitus has a significant effect on morphological, metabolic, physiological, and clinical aspects of the cornea. Morphological changes are manifest in the corneal epithelium, epithelial basement membrane and basement membrane complexes, stroma, and endothelium. The homeostasis of these structures can be altered by diabetes in both the non-stressed and the stressed cornea, causing myriad primary and postoperative manifestations. The polyol pathway appears to be involved in some of the pathophysiology mechanisms leading to these clinical entities and appears also to play a role in the treatment of some diabetic pathological processes associated with diabetes mellitus.

The Tampa Trephine technique with cat corneal endothelium.

The Tampa Trephine (Martin Marietta Speciality Components, Largo, FL, U.S.A.) penetrating keratoplasty technique uses a 7.0-mm corneal donor button with six rectangular 1 x 2-mm tabs of Bowman's layer, 75 microns in thickness, which are inserted into the recipient stroma beneath Bowman's layer. We evaluated the safety of the Tampa Trephine tissue-trephination method on the cat corneal endothelium combining vital staining and scanning electron microscopy, comparing it with the standard Weck trephination technique. The Tampa Trephine tissue trephination produces a donor button with a 6.7-mm diameter central area of normal endothelium. Localized peripheral areas of cellular loss, endothelial and Descemet's tears, endothelial detachment, and folding along the border of the trephination were observed with the Tampa Trephine method, all located in an area of < or = 150 microns, adjacent to the edge of the button. Standard trephination induced a localized peripheral area of endothelial damage < 50 microns in extension from the donor edge. A theoretic maximal 8.4% peripheral endothelial cell loss is induced with the Tampa Trephine trephination method, compared with a 2.8% loss with the standard procedure. The peripheral location of the alterations after the Tampa Trephine does not hinder the viability of the corneal endothelium, as it has been clinically observed.

Myopic keratomileusis in situ: a preliminary report.

We describe a technique and report a retrospective evaluation of myopic keratomileusis in situ. Surgery was performed on 32 eyes, with a mean follow-up time of 128.7 days (range 90 to 194 days). The average reduction of myopia was 8.48 diopters (D) when measured by refraction and 3.96 D by keratometry (minor axis). A statistically significant Pearson correlation coefficient of 0.49 (P = .01) was found between these two variables. Postoperative mean manifest spherical equivalent was -1.70 D (standard deviation 2.54 D). Mean cylinder correction increased -0.48 D (range -2.25 to 2.00 D). Uncorrected visual acuity improved after surgery in all eyes, but in 14 eyes the best corrected visual acuity diminished. Multiple regression model disclosed a limited predictability of the technique. Complications included diminution of best corrected visual acuity, under- and overcorrections, increase in keratometric astigmatism and cylinder correction, keratitis, delayed corneal epithelialization, interface amorphous deposits, monocular diplopia, interface epithelialization, and opacification. The most frustrating was an elusive postoperative cycloplegic refraction. In our hands, myopic keratomileusis in situ was not a technically safe, precise, and predictable technique for correction of myopia. Further improvement in the technique and equipment may provide better results.