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Submacular Surgery Trials Report No. 5

Submacular Surgery Trials Research Group^*

Arch Ophthalmol. 2005;123:78-88.

Objectives  To (1) summarize vision-targeted and general health-related quality-of-life scores at baseline and quantify the effect of the ophthalmic problem, (2) evaluate the strength of relations between visual acuity and interview scores, and (3) compare scores for patients who also had choroidal neovascular lesions in the fellow eye (bilateral cases) with those of patients who had choroidal neovascularization in only the study eye (unilateral cases) at time of enrollment in a randomized trial of surgical removal of subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or of idiopathic origin.

Design  Eligible patients had subfoveal choroidal neovascularization (including some classic choroidal neovascularization) and a visual acuity of 20/50 to 20/800 (Snellen equivalent), inclusive, in the eye to be assigned randomly to surgery or observation. Interviews that incorporated the 39-item version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) and 2 other instruments were conducted by telephone by trained interviewers before patients enrolled and were assigned randomly to surgery or observation. Information from baseline clinical examinations and fluorescein angiograms interpreted centrally by masked readers was used to classify patients as unilateral or bilateral cases and to provide potential explanations for variability of interview responses using linear regression models.

Results  The median overall NEI-VFQ score was 75 (interquartile range, 60-84). The median scores on individual subscales ranged from 55 (general vision) to 100 (color vision). The visual acuity of the better-seeing eye accounted for much of the variability in scores on most NEI-VFQ subscales; a 3-line difference in visual acuity was associated with a 10-point or greater difference in scores on 5 subscales after adjustment for other characteristics of patients and eyes. Scores on most scales of all 3 instruments differed between unilateral cases (n = 167) and bilateral cases (n = 58). Even after adjustment for visual acuity and reading speed of the better-seeing eye, age, gender, and scores on the other instruments, scores on the NEI-VFQ near and distance activities subscales differed by almost 13 and 10 points, respectively, between unilateral and bilateral cases. Neither age nor gender was an important independent explanatory variable for NEI-VFQ scores.

Conclusions  Unilateral and bilateral cases had vision-targeted health-related quality-of-life scores worse than those published for a reference population without eye disease. Furthermore, despite younger age, better visual acuity, and better short-term visual prognosis, bilateral cases had NEI-VFQ scores at baseline similar to those published for 2 groups of patients with age-related macular degeneration. Unidentified factors, in addition to the visual acuity of the better-seeing eye, affected patients’ perceptions of visual function.

*Group Information: A list of the members of the Submacular Surgery Trials (SST) Research Group who contributed data for the patients enrolled in this clinical trial was published in Arch Ophthalmol. 2004;122:1609-1610. The members of the SST Patient-Centered Outcomes Subcommittee who take responsibility for the content of this article on behalf of the SST Research Group are Barbara S. Hawkins, PhD; Päivi H. Miskala, PhD; Carol M. Mangione, MD, MSPH; Eric B. Bass, MD, MPH; Neil M. Bressler, MD; Ashley Childs Mann, MS; Li Ming Dong, PhD; and Marta J. Marsh, MS.

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