Purpose: To describe the incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus (CMV) retinitis in the era of highly active antiretroviral therapy (HAART). Design: Multicenter prospective observational study. Participants: Three hundred seventy-nine patients with AIDS and CMV retinitis (494 eyes). Methods: Follow-up every 3 months with medical history, ophthalmologic examination, and laboratory testing. Main Outcome Measures: Incidence of visual acuity loss to 20/50 or worse, to 20/200 or worse, and of doubling of the visual angle in eyes affected with CMV retinitis. Results: Among the 494 eyes with CMV retinitis, the baseline frequencies of visual acuity loss to 20/50 or worse and to 20/200 or worse were 29% and 15%, respectively. Over a median follow-up period of 3.1 years, the incidences of visual acuity loss to 20/50 or worse, to 20/200 or worse, and of doubling of the visual angle were 0.10/eye-year (EY), 0.06/EY, and 0.13/EY, respectively. Immune recovery was associated with a 42% reduction in vision loss to 20/50 or worse and with a 61% reduction in vision loss to 20/200 or worse after adjusting for confounding. Of the patients with immune recovery at baseline, 17% had immune recovery uveitis (IRU). In these patients, the incidence rate of 20/50 or worse vision was similar to that observed in patients without immune recovery (0.17/EY vs. 0.16/EY), but the incidence of 20/200 or worse vision was similar to that observed among patients with immune recovery (0.04/EY vs. 0.04/EY). Conclusions: Cytomegalovirus retinitis is associated with a substantial risk of incident vision loss in the era of HAART. Those who have HAART-induced immune recovery have approximately 50% lower risk of visual acuity loss. Presence of IRU at baseline attenuated the protective effect of immune recovery for moderate vision loss but not for blindness.
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