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A. M. Rentz, D. A. Revicki, V. S. Thomas; Psychometric Qualities of the National Eye Institute Visual Function Questionnaire-25 in Age-Related Macular Degeneration Patients in Two Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2007;48(13):2096.
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To evaluate the psychometric qualities of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in two ranibizumab clinical trials - ANCHOR and MARINA - in patients with age-related macular degeneration (AMD).
The NEI VFQ-25 was administered to 1,146 patients with subfoveal choroidal neovascularization due to AMD with minimally classic or occult with no classic types in MARINA and predominantly classic type in ANCHOR at baseline and months 1, 2, 3, 6, 9 and 12. The SF-36 Health Survey was administered at baseline, and months 6 and 12. Visual acuity and other clinical assessments were completed throughout the studies. Internal consistency reliability, construct validity, and responsiveness were examined.
For the combined sample, average age was 77 (range 52-96) with 59% women. Internal consistency reliability was 0.96 for the VFQ-25 total score and ranged from 0.62 (ocular pain) to 0.91 (near activities) for the subscales. At baseline, the VFQ-25 total and subscale scores were significantly correlated with SF-36 subscale and summary scores (p<0.05). Total score, and near activities, distance activities and dependency subscale scores were significantly correlated with best corrected visual acuity (BCVA) and contrast sensitivity, and all scores varied by different BCVA groups (p<0.001). The VFQ-25 total, near activities, distance activities and dependency scores were most responsive to changes in BCVA over 12 months (all p<0.001). Visual acuity responders reported significantly better VFQ-25 scores compared to non-responders (p<0.001).
The VFQ-25 total and subscales scores, especially near activities, distance activities, and dependency, are reliable and valid in patients with AMD. Based on these findings, the VFQ-25 represents a good measure of patient-reported vision-related quality of life outcomes for clinical trials comparing treatments for AMD.
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