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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
Responsiveness of the National Eye Institute Visual Function Questionnaire to changes in visual acuity: findings in patients with subfoveal choroidal neovascularization--SST Report No. 1.
Archives of Ophthalmology 2003 April
BACKGROUND: The National Eye Institute Visual Function Questionnaire (NEI-VFQ) measures vision-targeted quality of life, but it is unclear whether it is sensitive to changes within individuals over time.
OBJECTIVE: To determine the responsiveness of the NEI-VFQ to "within-individual" changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic causes, and who participated in randomized trials of submacular surgery.
METHODS: Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clinical trials of submacular surgery. Best-corrected visual acuity was measured by local vision examiners at 12 months after enrollment and, typically, by central "traveling" vision examiners at 24 months after enrollment. Changes in visual acuity and NEI-VFQ scores from 12 to 24 months were analyzed using linear regression methods.
RESULTS: Two-hundred eighteen patients had both interviews and visual acuity measurements at 12 and 24 months after enrollment. Changes in the overall NEI-VFQ score and in 9 of the subscales (near activities, dependency, driving, role difficulties, distance activities, mental health, general vision, peripheral vision, and social functioning) were related to changes in visual acuity of the better-seeing eye based on linear regression analysis (P<.05). In our analysis, a 3-line decrease in the visual acuity of the better-seeing eye was associated with 3.6- to 16.2-point decreases in the overall NEI-VFQ score and 9 subscale scores.
CONCLUSIONS: Most of the NEI-VFQ subscales were responsive to changes in the visual acuity of the better-seeing eye over a 12-month interval in this patient population. Thus, the NEI-VFQ can be used to measure change in vision-targeted quality of life over time to augment clinical measurements of visual acuity.
OBJECTIVE: To determine the responsiveness of the NEI-VFQ to "within-individual" changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic causes, and who participated in randomized trials of submacular surgery.
METHODS: Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clinical trials of submacular surgery. Best-corrected visual acuity was measured by local vision examiners at 12 months after enrollment and, typically, by central "traveling" vision examiners at 24 months after enrollment. Changes in visual acuity and NEI-VFQ scores from 12 to 24 months were analyzed using linear regression methods.
RESULTS: Two-hundred eighteen patients had both interviews and visual acuity measurements at 12 and 24 months after enrollment. Changes in the overall NEI-VFQ score and in 9 of the subscales (near activities, dependency, driving, role difficulties, distance activities, mental health, general vision, peripheral vision, and social functioning) were related to changes in visual acuity of the better-seeing eye based on linear regression analysis (P<.05). In our analysis, a 3-line decrease in the visual acuity of the better-seeing eye was associated with 3.6- to 16.2-point decreases in the overall NEI-VFQ score and 9 subscale scores.
CONCLUSIONS: Most of the NEI-VFQ subscales were responsive to changes in the visual acuity of the better-seeing eye over a 12-month interval in this patient population. Thus, the NEI-VFQ can be used to measure change in vision-targeted quality of life over time to augment clinical measurements of visual acuity.
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