Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
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Health- and vision-related quality of life among patients with choroidal neovascularization secondary to age-related macular degeneration at enrollment in randomized trials of submacular surgery: SST report no. 4.

PURPOSE: To describe the effect of subfoveal choroidal neovascularization (CNV) from age-related macular degeneration (AMD) on health-related quality of life (HRQOL) of patients at enrollment in two randomized clinical trials; to examine the relation of visual acuity to HRQOL; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics.

DESIGN: Randomized clinical trials.

METHODS: Two Submacular Surgery Trials (SST) recruited patients with AMD and either new subfoveal CNV (Group N Trial) or predominantly hemorrhagic CNV (Group B Trial). Health-related quality of life interviews included the National Eye Institute Visual Function Questionnaire [NEI-VFQ], the SF-36 Health Survey, and the Hospital Anxiety and Depression Scale [HADS]. Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease.

RESULTS: Interview data were analyzed for 789 AMD patients: 454 patients in the Group N Trial and 335 patients in the Group B Trial. Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ (mean overall scores of 65 for Group N and 63 for Group B). Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores. After adjusting for visual acuity of the better eye and other factors, bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial.

CONCLUSIONS: Subfoveal CNV profoundly affects vision-related quality of life. The effect is more pronounced with bilateral disease, even after controlling for visual acuity.

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