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 best-corrected 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.

Persistent macular holes - what is the best strategy for revision?

PURPOSE: This study aims to analyze the success rate and functional outcome after revision surgery of persistent idiopathic full-thickness macular holes in a large patient cohort and to identify the optimal tamponade strategy and the value of new adjunctive manipulation techniques for persistent macular hole (pMH) closure. METHODS: Retrospective, comparative, non-consecutive case series of all revisional surgeries for idiopathic pMH between 2011 and 2019 at the Eye Clinic Sulzbach were identified. Of 1163 idiopathic MH surgeries, 74 eyes of 74 patients had pMH. Of those, group 1 (n = 38) had vitrectomy with tamponade alone (20% sulfur hexafluoride gas, 15% hexafluoroethane gas, silicone oil 5000, Densiron®), while group 2 (n = 36) included tamponade with adjuvant manipulation (internal limiting membrane (ILM) translocation, subretinal fluid injection, epiretinal amniotic membrane, free retina graft, or autologous blood). Main statistical outcomes were anatomic closure rate, visual acuity (VA), minimum linear diameter (MLD), and base diameter (BD). RESULTS: Overall total anatomical success rate was 81.1% and mean VA improved 3.5 lines from LogMAR 1.03 ± 0.30 to 0.68 ± 0.38 (p < .001). Preoperative MLD or BD had no effect on total anatomic success (p = 0.074, p = 0.134, respectively). When comparing the two groups, slightly better anatomic success rates were achieved in group 1 (84.2%) compared to that in group 2 (77.8%) (p = 0.68). Final VA in group 1 (LogMAR 0.67 ± 0.39) outperformed group 2 (LogMAR 0.86 ± 0.38) (p = 0.03). CONCLUSIONS: Revisional surgery for persistent idiopathic MH with tamponade alone had comparable anatomical closure but better VA outcomes, compared to tamponade with adjuvant manipulation.