PREVALENCE AND ASSOCIATIONS OF MYELINATED RETINAL NERVE FIBERS: Results From the Population-Based Gutenberg Health Study.

PURPOSE: To determine the prevalence, ocular, and systemic associations of myelinated retinal nerve fibers (MRNF) in a Caucasian cohort. METHODS: The Gutenberg Health Study (GHS) is a population-based, prospective cohort study encompassing 15,010 subjects in Germany. Gutenberg Health Study participants, aged 35 to 74 years, stratified for gender, decades of age, and residence were examined for ophthalmologic and systemic conditions. Optic disc centered and macular photographs were reviewed for the presence of MRNF. RESULTS: In 25,728 eyes of 12,906 participants (86.0% of the cohort), the prevalence of MRNF was 0.4%. In a binary logistic regression analysis, MRNF was positively associated with history of stroke (OR, 6.8; 95% CI, 2.9-16.1; P < 0.001). Myelinated retinal nerve fibers was not associated with age, sex, cardiovascular conditions other than stroke or ocular parameters, such as refraction, visual acuity, intraocular pressure, or central corneal thickness. CONCLUSION: This population-based study provides novel data on the prevalence of MRNF in Western Europe. We report a positive association between history of stroke and MRNF. It adds an additional retinal sign for stroke and calls for further studying of the behavior of oligodendrocytes within cerebrovascular diseases.

A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt® Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension.

Background: The aim of this study was to demonstrate the equivalence of generic dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open-angle glaucoma or ocular hypertension. Methods: This prospective, monocentric, double-masked, active-controlled crossover phase III study included 32 patients. After washout, patients were randomized to reference product (Trusopt®) or test product (dorzolamide 2% eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover were performed. Drops were applied t.i.d. The primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, and safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within the sequence as effects was performed and an additional post hoc ANCOVA including the baseline IOP was also performed. Results: 34 patients were randomized and analyzed in the safety population. The per-protocol population included 32 patients. According to the self-report, all patients were >80% compliant. Under the ANCOVA model, the 90% confidence interval for the average change of the IOP -0.27 mmHg (-1.17 mmHg-0.64 mmHg) is included by the acceptance range -1.5 mmHg to +1.5 mmHg after excluding 2 patients, which had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments. Conclusions: This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution. Trial Registration. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).

Bleb grading by photographs versus bleb grading by slit-lamp examination.

PURPOSE: Using a bleb-grading system clinically facilitates long-term follow-up of patients with previous glaucoma surgery. Clinical evaluation of these patients can be challenging for untrained ophthalmologists. Morphological bleb configuration might influence planning of follow-up visits in glaucoma patients due to different and individual prognosis after trabeculectomy. In this study, we compared the MaBAGS (Mainz Bleb Appearance Grading System), a classification system for filtering blebs with other classification systems (MBGS/Moorfields Bleb Grading System, IBAGS/Indiana Bleb Appearance Grading Scale) in reference to usability and reliability and compare it to grading by bleb photographs. METHODS: Forty-two eyes of 31 patients after trabeculectomy were included. Three observers, two senior and one junior observer, graded all blebs using MaBAGS, MBGS and IBAGS during slit-lamp examination. Bleb photographs were reviewed at least 4 weeks after clinical examination. Statistical analysis was performed to determine agreement between the observers using intraclass correlation coefficients. RESULTS: With MaBAGS, excellent and good levels of agreement were found for vascularity indices, Seidel test and transparency. Parameters for area and height yielded moderate agreement, while indices for conjunctival mobility and microcysts failed to show satisfying levels of agreement. Using MBGS resulted in excellent and good interobserver consistency for parameters regarding subconjunctival blood, Seidel test, and central and peripheral vascularity. Height and nonbleb vascularity reached moderate levels of agreement. Agreement for area parameters was low. With IBAGS, good levels of agreement were found for height and vascularity, and moderate for extent. In all grading systems, consistency was considerably better between the two experienced observers compared to the inexperienced grader. CONCLUSIONS: MaBAGS shows good reproducibility. Using such a grading system improves precision of the description of a highly variable clinical finding. The reliability of grading by slit-lamp examination exceeds that of grading on photographs.

Comparison of Rebound Tonometry, Perkins Applanation Tonometry and Ocular Response Analyser in Mucopolysaccharidosis Patients.

AIMS: To investigate the feasibility and to compare three devices measuring intraocular pressure (IOP) in mucopolysaccharidosis patients (MPS): iCare rebound tonometer (RT), Perkins applanation tonometer (PAT) and ocular response analyzer (ORA). METHODS: MPS patients who underwent at least two examinations out of: RT, PAT and ORA at the same visit were identified and retrospectively analyzed in this study. RESULTS: 17 patients fulfilled the inclusion criterion. In all 17 patients IOP measurements were performed with RT (34 eyes) and ORA (33 eyes), while PAT measurement was possible in only 12 (24 eyes) patients. The RT, corneal-compensated intraocular pressure (IOPcc) and Goldmann-correlated intraocular pressure (IOPg) differed relevantly from IOP assessed with PAT. Corneal clouding in MPS patients correlated positively with PAT, RT and IOPg (r = 0.3, 0.5, and 0.5 respectively), but not with IOPcc (r = 0.07). The MPS-related corneal clouding correlated positively with biomechanical corneal parameters assessed with ORA: corneal hysteresis (r = 0.77) and corneal resistance factor (r = 0.77) either. CONCLUSIONS: RT and ORA measurements were tolerated better than applanation tonometry in MPS patients. IOP measurements assessed with RT and ORA differed relevantly from PAT. Corneal-compensated IOP assessed with ORA seems to be less affected by the MPS-related corneal clouding than applanation or rebound tonometry. RT and ORA measurements should be preferred for IOP assessment in patients with MPS.

Irregularity of the posterior corneal surface after curved interface femtosecond laser-assisted versus microkeratome-assisted descemet stripping automated endothelial keratoplasty.

PURPOSE: During donor tissue preparation for Descemet stripping automated endothelial keratoplasty (DSAEK), either microkeratome or femtosecond laser can be used for intrastromal cutting. We compared morphological and functional outcomes after DSAEK using both cutting techniques. METHODS: In this retrospective study, 22 uneventful DSAEK surgeries were reviewed. Eight donor corneas were prepared for DSAEK using the VisuMax femtosecond laser (Carl Zeiss Meditec AG, Jena, Germany). Fourteen corneas were processed using an Amadeus II microkeratome (Ziemer Ophthalmic Systems AG, Port, Switzerland). The postoperative best spectacle-corrected visual acuity was measured. Furthermore, corneal optical coherence tomography scans (RTVue; Optovue, Fremont, CA) were conducted and analyzed for graft cornea thickness and posterior surface irregularities using regression analysis (SPSS; IBM, Chicago, IL) on a second-order polynomial curve as a model for the posterior surface. RESULTS: The graft thickness was 166.3 ± 58.2 µm (mean ± SD) in the femtosecond laser group and 172.7 ± 48.2 µm in the microkeratome group. The best-corrected visual acuity of 0.48 ± 0.20 (logarithm of the minimum angle of resolution) in the femtosecond laser group was significantly poorer when compared with 0.33 ± 0.11 in the microkeratome group (P = 0.038). Moreover, the root mean square error between the posterior corneal surface and an ideal parabola surface was significantly higher in the femtosecond laser group (9.9 ± 2.2 µm) than in the microkeratome group (5.7 ± 2.2 µm; P < 0.001). CONCLUSIONS: Our study underlines the current superiority of a microkeratome-assisted preparation of the stromal-endothelial lamella before DSAEK surgery compared with the curved interface femtosecond laser-assisted processing.