Ganekal, Sunil

Abstract Purpose: The purpose of the study was to evaluate the efficacy of Sustained-release Intravitreal Dexamethasone implant (Ozurdex; Allergan Inc., Irvine, CA) during vitrectomy in preventing proliferative vitreoretinopathy (PVR). Methods: Double-blind, prospective, randomized, placebo-controlled trial. Eighty consecutive patients diagnosed with rhegmatogenous retinal detachment with high-risk PVR were randomized to study and control groups ( n = 40 each). Study group/Adjunct group (group 1) patients underwent vitrectomy with Sustained-release Intravitreal Dexamethasone implant (0.7 mg). In the control group (group 2), a similar surgery was performed without the use of a dexamethasone implant. Patients were evaluated at 1 month, 3 months, and 6 months after surgery. Postoperative retinal reattachment, recurrence of PVR, best-corrected visual acuity, and complications at the end of 6 months were compared between the two groups. Results: At 6 months postsurgery, 68.7% of patients had reattached retina. There was no significant difference ( P > 0.05) in retinal reattachment in both of the groups. The rate of postoperative PVR in the control group was 56%; in the study group, the rate was 46% ( P > 0.05), which proves statistically insignificant. In addition, there was no statistically significant difference in visual outcomes between the two groups ( P > 0.05), and no significant difference in the complication rate and drug toxicity was noted between the two groups. At 6 months, fewer adjunct patients had Cystoid macular edema or a foveal thickness of >300 μm compared with controls ( P = 0.003, P = 0.031). Conclusions: This study fails to prove the efficacy of the intraoperative use of Sustained-release Intravitreal Dexamethasone implant for the prevention of postoperative PVR or improvement in final visual acuity but it does reduce inflammation and CME. At the same time, no significant complications could be attributed to the treatment.