To present visual acuity (VA) and related findings from patients enrolled in o ne of the Submacular Surgery Trials (SST) evaluating surgical removal versus obs ervation of subfoveal choroidal neovascularization secondary to age related mac ular degeneration (SST Group N Trial). Randomized clinical trial. Eligible patie nts had age related macular degeneration with subfoveal choroidal neovasculariz ation, some with a classic pattern on fluorescein angiography, and best correct ed VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no tre atment in the macula. Any contiguous blood had to account for < 50%of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2 ]) . Randomization was stratified by VA and by clinical center. All patients were s cheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes. A successful outcome was defined a priori to be ei ther improvement of BCVA or VA no more than 1 line (7 letters) worse than baseli ne at the 24 month examination. Of 454 patients enrolled, 228 study eyes were a ssigned to observation and 226 to surgery. The percentages of eyes that had succ essful outcomes were similar in the 2 arms: 44%assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24 month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initiall y phakic eyes had cataract surgery by the 24 month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occ urred in 12 surgery eyes (5%) and 1 observation eye. Submacular surgery, as per formed in this clinical trial, did not improve or preserve VA for 24 months in m ore eyes than observation and is not recommended for patients with similar lesio ns.
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