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Adam Turpcu, Shoshana Colman, Ivan J. Suner, Neil M. Bressler, Rohit Varma, Paul Lee, Chantal Dolan, James Ward, Linda Yau; The Responsiveness of the National Eye Institute Visual Function Questionniare-25 (NEI VFQ-25) to Visual Acuity Gains in Diabetic Macular Edema Patients. Invest. Ophthalmol. Vis. Sci. 2012;53(14):6346.
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To examine the responsiveness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) by using data from the RIDE and RISE trials in diabetic macular edema (DME) and the change in the NEI VFQ-25 associated with a ≥15-letter change in best corrected visual acuity (BCVA).
In RIDE and RISE, participants were assigned randomly to monthly intravitreal ranibizumab at 0.5-mg (n=127 in RIDE, n=125 in RISE), 0.3-mg (n=125 in RIDE, n=125 in RISE), or sham (n=130 in RIDE, n=127 in RISE) for 24 months. BCVA measurements were obtained monthly through 24 months. The NEI VFQ-25 is a questionnaire that measures patient-reported vision-related function in day-to-day activities. The NEI VFQ-25 was administered at baseline and months 6, 12, 18, and 24. Data were analyzed separately for RIDE and RISE, and treatment groups were pooled within each trial. The responsiveness in the NEI VFQ-25 from baseline to month 12 was estimated using regression models adjusted for the baseline VFQ score, month 12 BCVA change from baseline, gender, and age.
Participants were categorized into 3 subgroups according to level of BCVA change (≥15 letters gained, <15 letters lost or gained, or ≥15 letters lost) from baseline to 12 months. The mean change in the NEI VFQ-25 composite score from baseline to 12 months differed among the 3 subgroups. Regression models estimated that the difference in the NEI VFQ-25 associated with a ≥15-letter gain in BCVA over 12 months was 8.7 (95% CI: 5.9 to 11.5) points for the composite score in RIDE. Similarly, the regression models estimated that the difference in the NEI VFQ-25 associated with a ≥15-letter gain in BCVA over 12 months was 8.3 (95% CI: 5.8 to 10.7) points for the composite score in RISE.
These analyses support the use of the NEI VFQ-25 as a responsive measure of vision-related function in DME patients. Data from RISE and RIDE suggest a gain in the NEI VFQ-25 score between 6 and 11 points corresponds to a ≥15-letter gain in BCVA over 12 months.
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