Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: ophthalmic findings: SST report no. 13.
OBJECTIVE
To present best-corrected visual acuity (BCVA) findings and other clinical outcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration.


METHODS
Randomized clinical trial (SST Group B Trial).


METHODS
Eligible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm2) composed of at least 50% blood (either blood or CNV underlying the center of the foveal avascular zone) and BCVA of 20/100 to light perception in the study eye.


METHODS
Patients were assigned randomly at time of enrollment to observation or surgical removal of blood and any associated CNV.


METHODS
A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in VA, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24-month examination based on an intent-to-treat analysis.


RESULTS
Of 336 patients enrolled, 168 were assigned to each treatment arm; treatment arms were balanced by baseline characteristics. Of 1501 expected examinations 3 months through 36 months after baseline, 1370 (91%) were performed. Loss of > or =2 lines (> or =8 letters) of VA occurred in 56% of surgery eyes, versus 59% of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, surgery more often prevented such loss: 36% in the observation arm versus 21% in the surgery arm at the 24-month examination (chi2 P = 0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44% in the surgery arm, compared with 6% in the observation arm. Twenty-seven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observation arm, had a rhegmatogenous retinal detachment (RD).


CONCLUSIONS
Submacular surgery as performed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhegmatogenous RD, but did reduce the risk of severe VA loss in comparison with observation. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.
Bressler
Neil M
NM
SST Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. nmboffice@jhmi.edu
Bressler
Susan B
SB
Childs
Ashley L
AL
Haller
Julia A
JA
Hawkins
Barbara S
BS
Lewis
Hilel
H
MacCumber
Mathew W
MW
Marsh
Marta J
MJ
Redford
Maryann
M
Sternberg
Paul
P
Thomas
Matthew A
MA
Williams
George A
GA
D000368:Aged; D000369:Aged, 80 and over; D002832:Choroid Hemorrhage / Q000503:physiopathology / Q000601:surgery*; D020256:Choroidal Neovascularization / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D015350:Contrast Sensitivity / Q000502:physiology; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D007431:Intraoperative Complications; D008268:Macular Degeneration / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011932:Reading; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*