To present and compare findings from health related quality of life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age related macular degeneration versus observation. Randomized clinical trial. El igible patients had predominantly hemorrhagic subfoveal choroidal neovascular le sions (total lesion size of > 3.5 disc areas, area of blood at least 50%of the lesion area, and at least 75%of blood posterior to the equator) and best corre cted visual acuity (VA) of 20/100 to < 20/1600 but at least light perception in the study eye. Three hundred thirty six patients enrolled after baseline qualit y of life interviews, 168 assigned to each of surgery or observation. Clinical and HRQOL data were collected before randomization and at 6, 12, 24, 36, and 48 months after enrollment. Baseline clinical evidence was used to stratify patien ts as having unilateral or bilateral neovascularization at the time of randomiza tion. The HRQOL interviews included the Na tional Eye Institute Visual Function Questionnaire (NEI VFQ), the 36 item Sh ort Form Health Survey, and the Hospital Anxiety and Depression Scale. Two year change in NEI VFQ. At 24 months after enrollment, overall NEI VFQ scores had a median decrease of 1 point from baseline in the observation arm (95%confidenc e interval [CI]:-4 to 3 points) and no change in the surgery arm (95%CI:-3 to 3 points) (P=0.70). Changes from baseline on NEI VFQ subscales also were simil ar between treatment arms. Differences in scores by unilateral or bilateral invo lvement seen at baseline in each treatment arm persisted throughout follow up f or most outcomes. Planned analyses stratified by VA showed trends (P=0.17) in fa vor of surgery at 24 months in the patients with baseline VA greater than 20/200 for the NEI VFQ scale (3.5 point median increase from baseline in the surgery arm [95%CI:-4 to 7]vs. a 1 point median loss from baseline in the observat io n arm [95%CI:-6 to 4]). No difference was detected with respect to vision t ar geted quality of life outcomes for patients randomized to surgery or observati on in the SST Group B Trial.
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