Longitudinal Study of Ocular Complications of AIDS (LSOCA)

Ocular abnormalities in patients with AIDS were first reported in 1982. The most common
finding is a non-infectious "HIV retinopathy", characterized by cotton wool spots,
intraretinal hemorrhages, and/or microaneurysms. These changes occur in approximately 50
percent of patients with AIDS. HIV retinopathy alone is not typically associated with
clinical loss of vision, but functional deficits in patients with AIDS without other ocular
complications may be due to this phenomenon.

CMV retinitis has had the most clinical importance of all the associated complications of
AIDS. It is commonly seen in late stage AIDS, and even when treated has the potential to
cause substantial loss of vision. CMV retinitis is also the most costly AIDS-related
opportunistic infection; the mean monthly cost of treatment has been estimated at $7,825.
The incidence of CMV retinitis has varied with changes in the therapeutic and prophylactic
strategies for AIDS and its complications. It has been on the decline in recent years
related to the increased use of highly active anti-retroviral therapy (HAART).

Other ocular complications of AIDS such as ocular toxoplasmosis, herpes zoster retinitis,
and pneumocystis choroidopathy occur less frequently than CMV retinitis and HIV retinopathy.
Their frequency has also changed over the course of the AIDS epidemic.

Because the epidemiology of AIDS is rapidly evolving, with HIV becoming more like a chronic
disease, new information is needed on the incidence and course of ocular complications. We
have little information about the effect of HAART therapy over time on changes in immune
status and the risk of ocular complications of AIDS. More information is also needed to
determine who is at risk for developing ocular complications of AIDS, and how treatment is
affecting their visual function, quality of life, and survival.

The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is prospective observational
study of patients with AIDS. Patients with a prior diagnosis of AIDS according to the 1993
Centers for Disease Control and Prevention (CDC) criteria with or without ocular
complications will be enrolled over a 4 year period. Approximately 2,000 patients will be
enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between
300 and 600 patients. Followup visits for patients without ocular complications will be
scheduled every 6 months. Followup visits for patients with ocular complications at
baseline or diagnosed during followup will be every 3 months. Followup data will include
eye examinations, fundus photographs, visual function testing, medical history, hematology
and serum chemistry, and collection of plasma and blood cells for banking. Analysis of
banked specimens will include HIV RNA levels and CMV DNA levels.

Males and females age 13 years and older with diagnosis of AIDS will be eligible