Laser Flare Photometry in Primary Rhegmatogenous Retinal Detachment: an Evaluation of 2487 Cases

Purpose: Exploratory analysis associated with the prospective, multicenter, randomized PRIVENT trial. To characterize the associations between laser flare photometry and anatomical and epidemiological features of rhegmatogenous retinal detachment (RRD). Methods: We measured laser flare values of all 3048 pre-screened patients excluding those with comorbidities. A mixed regression analysis evaluated the strength of the influencing factors age, sex, lens status, presence and extent of RRD on laser flare. Results: RRD was more frequent in men (65.8%) than in women (34.2%, p<0.001) and in right (52%) than in left eyes (48%, p=0.045). Phakic RRD affected less quadrants and was less likely to be associated with macula off status than pseudophakic RRD (48.4% vs 58.0% macula off, 23% vs 31% ≥3 quadrants, p<0.001). Laser flare of affected eyes was significantly higher compared to fellow eyes (12.6 ± 15.2pc/ms vs. 8.3 ± 7.4pc/ms, p<0.001). The factors age, sex, lens status, presence of RRD and the number of quadrants affected were independent influencing factors on laser flare. R2 was 0.145 for phakic and 0.094 for pseudophakic eyes. Conclusions: The results indicate that there may be more factors affecting laser flare than previously assumed. This might limit flare as predictive value for PVR and retinal re-detachment

Intravitreal 5-Fluorouracil and Heparin to Prevent Proliferative Vitreoretinopathy Results from a Randomized Clinical Trial

Purpose: Proliferative vitreoretinopathy (PVR) is the major cause for surgical failure after primary rhegmatogenous retinal detachment (RRD). So far, no therapy has been proven to prevent PVR. Promising results for 5-fluorouracil (5-FU) and low-molecular weight heparin (LMWH) in high-risk eyes have been reported previously. The objective of this trial was to examine the effect of adjuvant intravitreal therapy with 5-FU and LMWH compared with placebo on incidence of PVR in high-risk patients with primary RRD. Design: Randomized, double-blind, controlled, multicenter, interventional trial with 1 interim analysis. Participants: Patients with RRD who were considered to be at high risk for PVR were included. Risk of PVR was assessed by noninvasive aqueous flare measurement using laser flare photometry. Methods: Patients were randomized 1:1 to verum (200 mg/ml 5-FU and 5 IU/ml dalteparin) and placebo (balanced salt solution) intravitreally applied during routine pars plana vitrectomy. Main Outcome Measures: Primary end point was the development of PVR grade CP (full-thickness retinal folds or subretinal strands in clock hours located posterior to equator) 1 or higher within 12 weeks after surgery. For grading, an end point committee assessed fundus photographs. Secondary end points included bestcorrected visual acuity and redetachment rate. A group sequential design with 1 interim analysis was applied using the O'Brien and Fleming boundaries. Proliferative vitreoretinopathy grade CP incidence was compared using a Mantel-Haenszel test stratified by surgeon. Results: A total of 325 patients in 13 German trial sites had been randomized (verum, n = 163; placebo, n = 162). In study eyes, mean laser flare was 31 +/- 26 pc/ms. No significant difference was found in PVR rate. Primary analysis in the modified intention-to-treat population results were: verum 28% vs. placebo 23% (including not assessable cases as failures); odds ratio [OR], 1.25; 95% confidence interval [CI], 0.76-2.08; P = 0.77. Those in the per-protocol population were: 12% vs. 12%; OR, 1.05; 95% CI, 0.47-2.34; P = 0.47. None of the secondary end points showed any significant difference between treatment groups. During the study period, no relevant safety risks were identified. Conclusions: Rate of PVR did not differ between adjuvant therapy with 5-FU and LMWH and placebo treatment in eyes with RRD. (C) 2022 by the American Academy of Ophthalmolog

Regulation and revenue

Regulation, Taxation, Constitutional design, H2, H7, K2,