Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: ophthalmic findings: SST report no. 13

Abstract

Purpose: 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.

Design: Randomized clinical trial (SST Group B Trial).

Participants: 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.

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

Main outcome measure: 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.

Figure 1

A, Midphase frame from fluorescein angiogram showing an example of a predominantly hemorrhagic lesion (i.e., the area of blood that precludes the ability to determine if fluorescence from choroidal neovascularization [CNV] in that area is at least 50% of the area of the entire lesion), in which the hemorrhage extends under the geometric center of the foveal avascular zone. B, Midphase frame from fluorescein angiogram showing an example of a predominantly hemorrhagic lesion with fluorescence from CNV under the geometric center of the foveal avascular zone. C, Midphase frame from fluorescein angiogram showing an example of a large (>16 disc areas) predominantly hemorrhagic lesion. D, Midphase frame from fluorescein angiogram showing a predominantly hemorrhagic lesion that extends outside of the posterior pole.

Figure 2

Estimated percentages of study eyes with best-corrected visual acuity at each follow-up examination 2 lines (8 letters) or more worse than at baseline, by treatment arm. Solid line, observation eyes; dashed line, surgery eyes.

Figure 3

Estimated percentages of study eyes with best-corrected visual acuity at each follow-up examination 6 lines (28 letters) or more worse than at baseline by treatment arm. Solid line, observation eyes; dashed line, surgery eyes.

Figure 4

Estimated percentages of study eyes with fluorescein leakage from choroidal neovascularization (CNV) at baseline and at each follow-up examination by treatment arm. Solid line, observation eyes; dashed line, surgery eyes.

Figure 5

Cumulative percentage of eyes treated after identification by the ophthalmologist of fluorescein dye leakage from choroidal neovascularization (CNV) by specified follow-up examinations. Solid line, observation eyes; dashed line, surgery eyes.

Figure 6

Cumulative percentage of eyes that were phakic at baseline that had cataract surgery by specified follow-up times. Solid line, observation eyes; dashed line, surgery eyes.