Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: ophthalmic findings: SST report no. 11.
OBJECTIVE
To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial).


METHODS
Randomized clinical trial.


METHODS
Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for <50% of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2]).


METHODS
Randomization was stratified by VA and by clinical center. All patients were scheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes.


METHODS
A successful outcome was defined a priori to be either improvement of BCVA or VA no more than 1 line (7 letters) worse than baseline at the 24-month examination.


RESULTS
Of 454 patients enrolled, 228 study eyes were assigned to observation and 226 to surgery. The percentages of eyes that had successful outcomes were similar in the 2 arms: 44% assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24-month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initially phakic eyes had cataract surgery by the 24-month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occurred in 12 surgery eyes (5%) and 1 observation eye.


CONCLUSIONS
Submacular surgery, as performed in this clinical trial, did not improve or preserve VA for 24 months in more eyes than observation and is not recommended for patients with similar lesions. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.
Hawkins
Barbara S
BS
SST Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. bhawkins@jhmi.edu
Bressler
Neil M
NM
Miskala
Päivi H
PH
Bressler
Susan B
SB
Holekamp
Nancy M
NM
Marsh
Marta J
MJ
Redford
Maryann
M
Schwartz
Steven D
SD
Sternberg
Paul
P
Thomas
Matthew A
MA
Wilson
David J
DJ
D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D015350:Contrast Sensitivity / Q000502:physiology; D005260:Female; D005451:Fluorescein Angiography; D005584:Fovea Centralis / Q000473:pathology / Q000601:surgery*; D006801:Humans; D007431:Intraoperative Complications; D008268:Macular Degeneration / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D013508:Ophthalmologic Surgical Procedures; D011932:Reading; D016896:Treatment Outcome; D014481:United States; D014792:Visual Acuity / Q000502:physiology*