Studies of the Ocular Complications of AIDS (SOCA) Logitudinal Study of Ocular Complications of AIDS (LSOCA) Data Collection Forms (as of 24 April 2002)

摘要

This document contains the study data collection forms for the longitudinal Study of Ocular Complications of AIDS (LSOCA). LSOCA is a multicenter, prospective, cohort study of patients with AIDS. The objectives of the study are: (1) to monitor secular trends in the ocular complications with AIDS; (2) to determine the effect of changes in immune status induced by treatments for HIV and AIDS on the course of ocular complications of AIDS; (3) to determine risk factors for development of ocular complications of AIDS; and (4) to evaluate the effects of treatments for CMV retinitis and other ocular complications on visual function, quality of life, and survival. Patients (>=13 years of age) with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular complications are eligible for enrollment. Approximately 1,500 patients will be enrolled. All patients will be followed every 3 months. For patients with an ocular complication at enrollment, all follow-up visits will take place at clinic and include an eye examination. For patients without an ocular complication, clinic visits will take place every 6 months and they will be contacted by telephone between each clinic visit. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life questionnaires, and laboratory studies.