To report findings regarding health-related quality-of-life outcomesby treatment arm, both overall and within subgroups defined by selected baselinecharacteristics, among patients who participated in the Submacular SurgeryTrials (SST) randomized trial of observation vs surgical removal of subfovealchoroidal neovascular lesions that were either idiopathic or associated withocular histoplasmosis (SST Group H Trial).
Design and Methods
Eligible patients were 18 years or older and had subfoveal choroidalneovascularization (including a classic component on fluorescein angiography)and visual acuity of 20/50 to 20/800 inclusive in the eye randomly assignedto surgery or observation. Trained interviewers, who were masked to treatmentassignment, administered the National Eye Institute Visual Function Questionnaire(NEI-VFQ), the 36-Item Short-Form Health Survey (SF-36), and the HospitalAnxiety and Depression Scale (HADS) by telephone before enrollment and at6, 12, and 24 months after enrollment; early enrollees also had interviewsat 36 and 48 months. Baseline clinical examinations provided data regardingvisual acuity, other aspects of vision, and presence of unilateral or bilateralchoroidal neovascularization.
Of 225 patients interviewed at baseline and enrolled, 201, 190, and161 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 treatmentarms improved from baseline (median score, 75) to the 24-month interview.Patients in the surgery arm had 4-point larger improvements, on average, thanpatients in the observation arm (95% confidence interval, 1-8 points). Thelargest differences between treatment arms for mean 24-month improvementsfrom baseline were in the role difficulties subscale (9 points) and dependencysubscale (8 points), with larger mean improvements in the surgery arm. Scoreson the SF-36 worsened by approximately 1 point on the physical component summaryand improved by 2 points or more on the mental component summary in both treatmentarms by 24 months in comparison to baseline. The percentage of HADS-defined “definitecases” of both anxiety and depression declined from baseline in eachtreatment arm.
Vision-targeted quality of life improved more after submacular surgerythan with observation, supporting a possible small overall benefit of surgerysuggested by the ophthalmic outcomes reported elsewhere. Ophthalmologistsand patients similar to those who participated in the SST Group H Trial shouldbe aware of the effects of submacular surgery on specific aspects of vision-targetedquality of life as well as on ophthalmic outcomes when considering this treatmentapproach.
Submacular Surgery Trials Research Group. Surgical Removal vs Observation for Subfoveal Choroidal Neovascularization,Either Associated With the Ocular Histoplasmosis Syndrome or IdiopathicII. Quality-of-Life Findings From a Randomized Clinical Trial: SSTGroup H Trial: SST Report No. 10. Arch Ophthalmol. 2004;122(11):1616-1628. doi:10.1001/archopht.122.11.1616