Abstract :
PURPOE: To report complication and change in viion during 2 year of follow-up of patient with age-related macular degeneration aigned randomly to urgical removal or to laer photocoagulation of ubfoveal recurrent neovacular leion in a pilot trial deigned to tet method, to refine etimate of outcome rate, and to project patient accrual rate for a larger multicenter randomized trial to evaluate ubmacular urgery.
PATIENT AND METHOD: Eligible patient with previou laer photocoagulation of extrafoveal or juxtafoveal choroidal neovacularization econdary to age-related macular degeneration were enrolled at 15 collaborating clinical center. Aignment to treatment arm were made by peronnel at a central coordinating center. Adherence to eligibility criteria and treatment aignment wa aeed centrally at a photograph reading center. Patient were examined at 3, 6, 12, and 24 month after treatment for data collection purpoe. Outcome meaure reported include treatment complication, advere event, requirement for additional treatment, and 2-year change in viual acuity from baeline.
REULT: Of 70 patient enrolled, 36 were aigned to laer photocoagulation and 34 to ubmacular urgery; all were treated a aigned. One patient in each group died before the 2-year examination. Viual acuity wa meaured at the 2-year examination for 31 of the urviving patient (89%) in the laer arm and for 28 of the urviving patient (85%) in the urgery arm. The 2-year meaurement for 36 of the 59 patient (61%) were made by an examiner maked to treatment aignment and to the identity of the tudy eye. Improvement and loe of viual acuity were oberved in both treatment arm; 20 of 31 tudy eye (65%) in the laer arm and 14 of 28 tudy eye (50%) in the urgery arm had viual acuity 2 year after enrollment that wa better than or no more than 1 line wore than the baeline level. Change in viual acuity and the ize of the central macular leion from baeline to the 2-year examination were imilar in the treatment arm. Few eriou complication were oberved in either arm at the time of initial treatment; eriou advere event were rare. During follow-up, 11 laer-treated eye and 18 urgically treated eye had additional intraocular procedure.
CONCLUION: The data from thi pilot trial ugget no reaon to prefer ubmacular urgery over laer photocoagulation for treatment of patient with age-related macular degeneration who have leion imilar to thoe tudied in thi pilot trial. Any clinical trial deigned to compare ubmacular urgery with laer photocoagulation in eye with age-related macular degeneration and ubfoveal recurrent neovacular leion mut enroll everal hundred patient in order to reach a tatitically valid concluion regarding difference between thee two method of treatment with repect to either change in viual acuity or complication rate.
