Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: quality-of-life findings: SST report no. 14

Abstract

Purpose: To present and compare findings from health-related quality-of-life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age-related macular degeneration versus observation.

Design: Randomized clinical trial.

Participants: Eligible patients had predominantly hemorrhagic subfoveal choroidal neovascular lesions (total lesion size of >3.5 disc areas, area of blood at least 50% of the lesion area, and at least 75% of blood posterior to the equator) and best-corrected visual acuity (VA) of 20/100 to <20/1600 but at least light perception in the study eye. Three hundred thirty-six patients enrolled after baseline quality-of-life interviews, 168 assigned to each of surgery or observation.

Methods: Clinical and HRQOL data were collected before randomization and at 6, 12, 24, 36, and 48 months after enrollment. Baseline clinical evidence was used to stratify patients as having unilateral or bilateral neovascularization at the time of randomization. The HRQOL interviews included the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-item Short Form Health Survey, and the Hospital Anxiety and Depression Scale.

Main outcomes measure: Two-year change in NEI-VFQ.

Results: At 24 months after enrollment, overall NEI-VFQ scores had a median decrease of 1 point from baseline in the observation arm (95% confidence interval [CI]: -4 to 3 points) and no change in the surgery arm (95% CI: -3 to 3 points) (P = 0.70). Changes from baseline on NEI-VFQ subscales also were similar between treatment arms. Differences in scores by unilateral or bilateral involvement seen at baseline in each treatment arm persisted throughout follow-up for most outcomes. Planned analyses stratified by VA showed trends (P = 0.17) in favor of surgery at 24 months in the patients with baseline VA greater than 20/200 for the NEI-VFQ scale (3.5-point median increase from baseline in the surgery arm [95% CI: -4 to 7] vs. a 1-point median loss from baseline in the observation arm [95% CI: -6 to 4]).

Conclusions: No difference was detected with respect to vision-targeted quality-of-life outcomes for patients randomized to surgery or observation in the SST Group B Trial. This article contains additional online-only material available at www.ophsource.com/periodicals/ophtha.

Figure 1

Summaries (medians and interquartile ranges) of distributions of National Eye Institute Visual Function Questionnaire (NEI-VFQ) scores by scale and treatment arm at baseline. The leftmost pair representing the total group is for all patients in each treatment arm, the middle pair is for patients in each treatment arm who were classified as having unilateral cases at baseline, and the rightmost pair is for patients in each treatment arm who were classified as having bilateral cases at baseline. O = observation; S = surgery.

Figure 2

Summaries (medians) of distributions of overall National Eye Institute Visual Function Questionnaire scores at each interview time point by neovascular status of the two eyes and treatment arm. Dashed lines indicate the surgery treatment arm, and solid lines, the observation arm. At the 24-month time point, the vertical bars indicate the 95% median confidence interval.

Figure 3

Median changes in overall National Eye Institute Visual Function Questionnaire (NEI-VFQ) scale and subscale scores from baseline to follow-up interviews at each interview time point. Dashed lines indicate the surgery treatment arm, and solid lines, the observation arm. (Median changes for the subscales not shown remained at 0 throughout follow-up.)