SCORE2 Report 5: Vision-Related Function in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

Abstract

Purpose: To describe baseline vision-related function, measured with the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), in patients with macular edema secondary to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2); evaluate the baseline relationship between NEI VFQ-25 scores with visual acuity letter score (VALS) and central retinal thickness; and compare baseline NEI VFQ-25 scores in SCORE2 participants with those in normal-vision reference populations and patients in other retinal vein occlusion trials.

Design: Multicenter, noninferiority randomized controlled trial.

Methods: SCORE2 was designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema owing to CRVO or HRVO. SCORE2 enrolled 362 participants, including 305 with CRVO and 57 with HRVO. Analyses were of cross-sectional baseline data. The main outcome measures were baseline NEI VFQ-25 composite and subscale scores.

Results: SCORE2 participants' baseline NEI VFQ-25 composite and subscale scores are significantly lower compared with 3 normal-vision reference populations (P < .01; except for ocular pain score) and similar to patients in other retinal vein occlusion clinical trials. Baseline VALS in the better eye was correlated with baseline NEI VFQ-25 composite and subscale scores of general vision, near activities, role difficulties, dependency, and color vision, with correlations ranging from 0.19 to 0.26 (P < .05 for each score).

Conclusions: CRVO and HRVO patients in SCORE2 had significantly worse baseline patient-reported vision-related function than normal vision populations, despite the disease being primarily unilateral with typically excellent vision in the fellow eye.

Copyright © 2017 Elsevier Inc. All rights reserved.

Figures

Figure 1

NEI-VFQ-25 Results in SCORE2 Participants. The box in the box and whisker plot is the 25th to 75th percentile (the inner quartile range), with the median shown as a line within the box and the mean shown as a diamond. The whiskers extend to the minimum observation above the lower fence and maximum observation below the upper fence, which are defined as 1.5 times the inner quartile range below the 25th percentile and above the 75th percentile. The outliers, shown as circles, mark any observation below the lower fence or above the upper fence.

Figure 2

Comparisons of Mean NEI-VFQ-25 Subscale Scores with 95% Bonferroni-corrected Confidence Intervals of SCORE2 Participants with Three Normal Vision Populations.,, Note that Mangione composite score confidence intervals are not available.

Figure 3

Comparisons of Mean NEI-VFQ-25 Subscale Scores with 95% Bonferroni-corrected Confidence Intervals of SCORE2 Participants with Four Retinal Vein Occlusion Clinical Trial Populations, CRUISE, COPERNICUS, BRAVO, and VIBRANT.