CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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Visual loss in patients with cytomegalovirus retinitis and acquired immunodeficiency syndrome before widespread availability of highly active antiretroviral therapy.

OBJECTIVE: To evaluate rates and causes of visual loss among patients with acquired immunodeficiency syndrome (AIDS) and cytomegalovirus (CMV) retinitis before widespread availability of highly active antiretroviral therapy (HAART).

METHODS: Data from 681 patients with AIDS and newly diagnosed or relapsed CMV retinitis who enrolled in 3 clinical trials conducted by the Studies of Ocular Complications of AIDS (SOCA) Research Group (between 1990 and 1996) were combined to evaluate the rates and causes of visual loss. Visual acuity and visual field (Goldmann visual fields) losses were evaluated.

RESULTS: The rates of visual loss in eyes with CMV retinitis were substantial in all 3 clinical trials, ranging from 51.7 to 97.7 events per 100 eye-years for loss of visual acuity to worse than 20/40 and 18.9 to 49.1 events per 100 eye-years for loss of visual acuity to 20/200 or worse. The 2 major causes of visual loss were retinitis, involving either the macula or the optic nerve, and retinal detachment. After 1992, visual outcomes improved significantly. Antiretroviral therapy was associated with a 30% reduction in the risk of visual acuity loss (relative risk, 0.70; P =.02).

CONCLUSIONS: In the pre-HAART era, visual morbidity was substantial. However, there was a secular trend for improved outcomes. The principal causes of visual loss were CMV involvement of the posterior retina and retinal detachment.

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