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Endolaserless vitrectomy with aflibercept for proliferative diabetic retinopathy-related vitreous hemorrhage (LASER LESS TRIAL):1-Year Results.

Dennis M Marcus, Davis Starnes, Harveen Walia, Amina Farooq, Heather Frazier, William B Marcus, Evin M Samy, Robert A Lalane, Harinderjit Singh, Caitlen Taylor

Objective: We report the 1-year safety and efficacy results of vitrectomy without endolaser for proliferative diabetic retinopathy (PDR)-related vitreous hemorrhage (VH).

Methods: All eyes received one preoperative and intraoperative IAI (2 mg). The q8week group received postoperative IAI every 4 weeks through week 16 followed by q8week IAI. The q16week group received postoperative IAI every 4 weeks through week 8 followed by q16week IAI. All patients were examined every 4 weeks; PRN IAI for PDR progression or diabetic macular edema (DME) was allowed.

Results: Thirty-one eyes from 40 patients were randomized. Through 52 weeks, endophthalmitis, progression of traction retinal detachment, iris/angle neovascularization and neovascular glaucoma were not observed. The q8week and q16week groups received an average of 8.4 and 5.4 injections, respectively, through 52 weeks. Adverse events at any time through 52 weeks such as worsened visual acuity>30 letters (6 eyes), new rhegmatogenous retinal detachment (1 eye), and recurrent VH (4 eyes) occurred infrequently and were more common in the q16week group. Preoperative average visual acuity (VA) was 37 letters (20/200) for randomized eyes. Endolaserless vitrectomy resulted in statistically significant 52-week visual acuity 33 letter gain to 72 letters (20/40). Visual acuity outcomes favored (not statistically significant) the q8week group where average acuity was 77 letters (20/32) with a 52-week 40 letter gain versus 66 letters (20/50) with a 52-week 24 letter gain in the q16week group.

Conclusion: Endolaserless vitrectomy with aflibercept demonstrates 52-week safety with significant VA improvement.