Prospective randomized trial of vitrectomy or observation for stage 2 macular holes

PURPOSE: To determine the risks and benefits of vitrectomy surgery in eyes with stage 2 macular holes, METHODS: A multicentered, controlled, randomized clinical trial was performed with participation of 16 community and university-based ophthalmology clinics, Thirty-six eyes with stage 2 macular holes and 12 months of follow-up were studied, Pars plana vitrectomy with separation of the posterior hyaloid membrane and intraocular injection of perfluoropropane (C3F8) was followed by postoperative face down positioning for two weeks, This protocol was compared with observation alone, Outcome variables included anatomic closure of the macular hole, macular hole size, and four standardized measures of vision, RESULTS: At 12 months, 15 (71%) of 21 eyes randomly assigned to observation progressed to stages 3 or 4, compared with three (20%) of 15 eyes randomly assigned to surgery (P < .006), Compared with eyes randomly assigned to observation, eyes randomly assigned to surgery had significantly smaller hole diameters (P < .01) and significantly better visual acuity outcomes, as measured by the Word Reading (P = .02) and Potential Acuity Meter (P = .002) charts, No significant differences were found for the Early Treatment Diabetic Retinopathy Study chart and Contrast Sensitivity test. CONCLUSION: Compared with observation alone, surgical intervention in stage 2 macular holes resulted in a significantly lower incidence of hole enlargement and appeared to be associated with better outcome in some measures of visual acuity.