Surgical removal vs observation for subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or idiopathic: II. Quality-of-life findings from a randomized clinical trial: SST Group H Trial: SST Report No. 10

Abstract

Objective: To report findings regarding health-related quality-of-life outcomes by treatment arm, both overall and within subgroups defined by selected baseline characteristics, among patients who participated in the Submacular Surgery Trials (SST) randomized trial of observation vs surgical removal of subfoveal choroidal neovascular lesions that were either idiopathic or associated with ocular histoplasmosis (SST Group H Trial).

Design and methods: Eligible patients were 18 years or older and had subfoveal choroidal neovascularization (including a classic component on fluorescein angiography) and visual acuity of 20/50 to 20/800 inclusive in the eye randomly assigned to surgery or observation. Trained interviewers, who were masked to treatment assignment, administered the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-Item Short-Form Health Survey (SF-36), and the Hospital Anxiety and Depression Scale (HADS) by telephone before enrollment and at 6, 12, and 24 months after enrollment; early enrollees also had interviews at 36 and 48 months. Baseline clinical examinations provided data regarding visual acuity, other aspects of vision, and presence of unilateral or bilateral choroidal neovascularization.

Results: Of 225 patients interviewed at baseline and enrolled, 201, 190, and 161 patients (respectively, 89%, 85%, and 88% of those eligible to be interviewed) were interviewed 12, 24, and 36 months later. The NEI-VFQ scores in both treatment arms improved from baseline (median score, 75) to the 24-month interview. Patients in the surgery arm had 4-point larger improvements, on average, than patients in the observation arm (95% confidence interval, 1-8 points). The largest differences between treatment arms for mean 24-month improvements from baseline were in the role difficulties subscale (9 points) and dependency subscale (8 points), with larger mean improvements in the surgery arm. Scores on the SF-36 worsened by approximately 1 point on the physical component summary and improved by 2 points or more on the mental component summary in both treatment arms by 24 months in comparison to baseline. The percentage of HADS-defined "definite cases" of both anxiety and depression declined from baseline in each treatment arm.

Conclusions: Vision-targeted quality of life improved more after submacular surgery than with observation, supporting a possible small overall benefit of surgery suggested by the ophthalmic outcomes reported elsewhere. Ophthalmologists and patients similar to those who participated in the SST Group H Trial should be aware of the effects of submacular surgery on specific aspects of vision-targeted quality of life as well as on ophthalmic outcomes when considering this treatment approach.

Figure 1

Summaries of distributions of National Eye Institute Visual Function Questionnaire (NEI-VFQ) scores by scale and treatment arm at baseline. The leftmost pair of bars for each scale is for all patients in each treatment arm; the middle pair of vertical bars is for patients in each treatment arm who were classified as unilateral cases; the rightmost pair of bars is for patients in each treatment arm who were classified as bilateral cases. Each vertical bar spans the interquartile range of the distribution. The black dot indicates the median of the distribution. Best possible score on each scale is 100 points. The observation arm (O) was composed of 113 patients (83 unilateral cases, 30 bilateral cases); the surgery arm (S), 112 patients (84 unilateral cases, 28 bilateral cases).

Figure 2

Median overall and subscale scores from the National Eye Institute Visual Function Questionnaire (NEI-VFQ) at each scheduled interview time by treatment arm. Best possible score on each subscale is 100 points. Solid lines indicate patients in the observation arm (n=113 at baseline); broken lines, patients in the surgery arm (n=112 at baseline).

Figure 3

Median overall National Eye Institute Visual Function Questionnaire scores at each interview time for unilateral cases and bilateral cases, as defined by the presence of choroidal neovascularization in the nonstudy (fellow) eye at baseline. Vertical lines at 24 months delimit the 95% confidence intervals of median scores. Best possible score is 100 points. Solid lines indicate patients in the observation arm (83 unilateral cases, 30 bilateral cases); broken lines, patients in the surgery arm (84 unilateral cases, 28 bilateral cases).

Figure 4

Mean changes in National Eye Institute Visual Function Questionnaire overall scores from baseline to each interview time by treatment arm. Vertical lines at 24 months delimit the 95% confidence intervals on mean changes. Positive changes indicate improvements from baseline scores. A, Unilateral cases. Solid line indicates patients in the observation arm (n=83 at baseline); broken line, patients in the surgery arm (n=84 at baseline). B, Bilateral cases. Solid line indicates patients in the observation arm (n=30 at baseline); broken line, patients in the surgery arm (n=28 at baseline).

Figure 5

Mean changes in National Eye Institute Visual Function Questionnaire scale scores from baseline to follow-up interviews at specified times. Vertical lines indicate 95% confidence intervals on mean changes to 24 months. For each subscale, the left panel of the pair presents mean changes among unilateral cases (83 in the observation arm and 84 in the surgery arm at baseline); the right panel, mean changes among bilateral cases (30 in the observation arm and 28 in the surgery arm at baseline). Positive changes indicate improvements from baseline scores. Solid lines indicate patients in the observation arm; broken lines, patients in the surgery arm.