Abstract
Purpose::
To examine the relationship between patient-reported visual function as assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and visual acuity using data from the MARINA trial.
Methods::
In MARINA, subjects were randomized 1:1:1 to monthly sham injection or injection with 0.3 mg or 0.5 mg ranibizumab. Only one eye per subject received treatment. Patient-reported visual function was collected using the NEI VFQ-25. Visual acuity was measured using the number of letters on the ETDRS chart. Regression analyses included only subjects whose better-seeing eye was the study eye at baseline. The dependent variable was defined as the change from baseline to month 12 in the overall composite score of the NEI VFQ-25. The independent variable was the change from baseline at month 12 in visual acuity. A second multivariate regression model was fit to the data with the same dependent and independent variables but controlling for treatment group, baseline NEI VFQ-25 composite score and baseline visual acuity.
Results::
In the uncontrolled regression model, the slope of the regression model for the NEI VFQ-25 composite change scores was 0.492 (P<0.0001) with an R-square of 0.284. When treatment group, baseline NEI VFQ-25 composite score and baseline VA were added to the model, the R-square increased to 0.40.
Conclusions::
In the MARINA trial, The change in NEI VFQ-25 composite score was moderately correlated with change in visual acuity over 12 months. A regression model of change in visual acuity, treatment group, baseline NEI VFQ-25 composite score and baseline visual acuity explained 40% of the variance in the NEI VFQ-25 composite score. This finding demonstrates that while changes in visual acuity and changes in patient reported visual function are related, visual acuity does not completely capture all aspects of function important to patients.
Clinical Trial::
www.clinicaltrials.gov NCT00056836
Keywords: age-related macular degeneration • quality of life • visual acuity