VITRECTOMY FOR PREVENTION OF MACULAR HOLES - RESULTS OF A RANDOMIZED MULTICENTER CLINICAL-TRIAL

Purpose: The purpose of this study is to assess the benefit of vitreou s surgery in preventing full-thickness macular holes in patients with impending (stage I)macular holes. Methods: A prospective randomized mu lticenter clinical trial was conducted on patients with full-thickness macular holes in their first eye (stage 3 or 4) and signs and symptom s of stage 1 macular holes in their fellow eye (study eye). The study eye was randomized to vitreous surgery or observation. Outcome was ass essed by standardized measurement of visual acuity, detailed clinical examination, fundus photographs, and fluorescein angiography. Results: A full-thickness macular hole developed in 10 (37%) of 27 patients in the vitrectomy group compared with 14(40%) of 35 patients randomized to observation (P = 0.81). This difference of 3% has a 95% confidence interval of (-21%,27%). Conclusion: The study was terminated because o f low recruitment. The authors were unable to prove (or disprove) the benefit of vitreous surgery in patients with stage 1 macular holes. Th e authors can state, however, that should a beneficial effect from vit rectomy exist, it would probably be minimal. Considering the cost and morbidity of vitreous surgery, a conservative approach for stage 1 mac ular hole might be appropriate.