Clinical Trials
November 2004

Surgical Removal vs Observation for Subfoveal Choroidal Neovascularization,Either Associated With the Ocular Histoplasmosis Syndrome or IdiopathicI. Ophthalmic Findings From a Randomized Clinical Trial: SubmacularSurgery Trials (SST) Group H Trial: SST Report No. 9

Submacular Surgery Trials Research Group
Author Affiliations

*Authors: The Writing Committee for SST ResearchGroup Report No. 9 served as authors and are responsible for its content.




Copyright 2004 American Medical Association. All Rights Reserved.Applicable FARS/DFARS Restrictions Apply to Government Use.2004

Arch Ophthalmol. 2004;122(11):1597-1611. doi:10.1001/archopht.122.11.1597

Objective  To present visual acuity findings and related outcomes from eyes ofpatients enrolled in a randomized trial conducted by the Submacular SurgeryTrials (SST) Research Group (SST Group H Trial) to compare surgical removalvs observation of subfoveal choroidal neovascular lesions that were eitheridiopathic or associated with ocular histoplasmosis.

Methods  Eligible patients 18 years or older had subfoveal choroidal neovascularization(new or recurrent) that included a classic component on fluorescein angiographyand best-corrected visual acuity of 20/50 to 20/800 in 1 eye (“studyeye”). Patients were examined 3, 6, 12, and 24 months after enrollmentto assess study outcomes and adverse events. Best-corrected visual acuitywas measured by a masked examiner at the 24-month examination. A successfuloutcome was defined a priori as 24-month visual acuity better or no more than1 line (7 letters) worse than at baseline.

Results  Among 225 patients enrolled (median visual acuity 20/100), 113 studyeyes were assigned to observation and 112 to surgery. Forty-six percent ofthe eyes in the observation arm and 55% in the surgery arm had a successfuloutcome (success ratio, 1.18; 95% confidence interval, 0.89-1.56). Medianvisual acuity at the 24-month examination was 20/250 among eyes in the observationarm and 20/160 for eyes in the surgery arm. The prespecified subgroup of eyeswith visual acuity worse than 20/100 at baseline (n = 92) had moresuccesses with surgery; 31 (76%) of 41 eyes in the surgery arm vs 20 (50%)of 40 eyes in the observation arm examined at 24 months (success ratio, 1.53;95% confidence interval, 1.08-2.16). Five (4%) of 111 eyes in the surgeryarm subsequently had a rhegmatogenous retinal detachment. Twenty-seven (24%)of 112 initially phakic eyes in the surgery arm (none in the observation arm)had cataract surgery during follow-up, all among patients older than 50 years.Recurrent choroidal neovascularization developed by the 24-month examinationin 58% of surgically treated eyes.

Conclusions  Overall, findings supported no benefit or a smaller benefit to surgerythan the trial was designed to detect. Findings support consideration of surgeryfor eyes with subfoveal choroidal neovascularization and best-corrected visualacuity worse than 20/100 that meet other eligibility criteria for the SSTGroup H Trial. Other factors that may influence the treatment decision includethe risks of retinal detachment, cataract among older patients, and recurrentchoroidal neovascularization and the possibility that additional treatmentwill be required after submacular surgery.