Effect of autologous platelet concentrate in surgery for idiopathic macular hole - Results of a multicenter, double-masked, randomized trial

Objective: To evaluate prospectively the efficacy and safety of autologous platelet concentrate (APC) as an adjuvant in surgery for idiopathic macular hole. Design: Multicenter, double-masked, randomized clinical trial. Setting: Four university-based ophthalmology clinics. Participants: One hundred ten patients with stage 3 or 4 idiopathic full-th ickness macular holes of less than 3 years' duration were randomized (53 ey es to the platelet group and 57 eyes to the control group). Interventions: Standardized macular hole surgery versus surgery combined wi th injection of an APC. In all cases, the procedure consisted of three-port pars plana vitrectomy, posterior hyaloid separation, and nonexpansile flui d-gas exchange. After the fluid-gas exchange, patients were randomized to r eceive either injection of an APC or no adjunctive treatment. After surgery , patients were positioned face down for 12 days. Platelet counts showed th at the concentrates contained a mean of 96.10(6) platelets (range, 82-102). Main Outcome Measures: Anatomic and functional evaluations were performed a t 1, 3, and 6 months after surgery in a double-masked fashion by an indepen dent observer. The main outcome was reapposition of the edge of the macular hole 1 month after surgery. Secondary outcomes were anatomic status at 3 a nd 6 months, changes in Early Treatment Diabetic Retinopathy Study score, a nd complications. Results: One month after surgery, the anatomic success rate in the platelet group was 52 of 53 (98%; 95% confidence interval, 0.90-1.00) versus 47 of 57 (82%; 95% confidence interval, 0.70-0.91) in the control group (P = 0.00 9, Fisher's exact test; relative risk, 0.11; 95% confidence interval, 0.01- 0.81), Visual acuity was not significantly different between the two groups at any timepoint, There were no complications specifically attributable to the platelet injection. Conclusion: Injection of APC improved significantly the anatomic success ra te of surgery for idiopathic macular holes of less than 3 years' duration, but postoperative visual acuity of the platelet group was not statistically different from the control group.