Submacular surgery trials randomized pilot trial of laser photocoagulationversus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes - Submacular surgery trials pilot study report number 1

PURPOSE: To report complications and changes in vision during 2 years of fo llow-up of patients with age-related macular degeneration assigned randomly to surgical removal or to laser photocoagulation of subfoveal recurrent ne ovascular lesions in a pilot trial designed to test methods, to refine esti mates of outcome rates, and to project patient accrual rates for a larger m ulticenter randomized trial to evaluate submacular surgery. PATIENTS AND METHODS: Eligible patients with previous laser photocoagulatio n of extrafoveal or juxtafoveal choroidal neovascularization secondary to a ge-related macular degeneration were enrolled at 15 collaborating clinical centers. Assignments to treatment arm were made by personnel at a central c oordinating center. Adherence to eligibility criteria and treatment assignm ent was assessed centrally at a photograph reading center. Patients were ex amined at 3, 6, 12, and 24 months after treatment for data collection purpo ses, Outcome measures reported include treatment complications, adverse eve nts, requirements for additional treatment, and 2-year changes in visual ac uity from baseline. RESULTS: Of 70 patients enrolled, 36 were assigned to laser photocoagulatio n and 34 to submacular surgery; all were treated as assigned. One patient i n each group died before the 2-year examination. Visual acuity was measured at the 2-year examination for 31 of the surviving patients (89%) in the la ser arm and for 28 of the surviving patients (85%) in the surgery arm. The 2-year measurements for 36 of the 59 patients (61%) were made by an examine r masked to treatment assignment and to the identity of the study eye. Impr ovements and losses of visual acuity were observed in both treatment arms; 20 of 31 study eyes (65%) in the laser arm and 14 of 28 study eyes (50%) in the surgery arm had visual acuity 2 years after enrollment that was better than or no more than 1 line worse than the baseline level. Changes in visu al acuity and the size of the central macular lesions from baseline to the 2-year examination were similar in the treatment arms. Few serious complica tions were observed in either arm at the time of initial treatment; serious adverse events were rare. During follow-up, 11 laser-treated eyes and 18 s urgically treated eyes had additional intraocular procedures. CONCLUSIONS: The data from this pilot trial suggest no reason to prefer sub macular surgery over laser photocoagulation for treatment of patients with age-related macular degeneration who have lesions similar to those studied in this pilot trial. Any clinical trial designed to compare submacular surg ery with laser photocoagulation in eyes with age-related macular degenerati on and subfoveal recurrent neovascular lesions must enroll several hundred patients in order to reach a statistically valid conclusion regarding diffe rences between these two methods of treatment with respect to either change s in visual acuity or complication rates. (C) 2000 by Elsevier Science Inc. All rights reserved.