ADVANCE GLAUCOMA INTERVENTION STUDY

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This is a revised application from the University of Michigan to participate in the Advanced Glaucoma Intervention Study (AGIS). Our qualifications to participate in AGIS are detailed, including patient availability. During the 18-month period ending June, 1986, 36 eyes of 26 AGIS-eligible patients were treated by Dr. Lichter, an annual rate of 24 eligible eyes per year. In addition approximately an equal number of eligible patients were treated by the co-principle investigator and by our glaucoma clinic; thus we expect to enroll at least 25 patients during the first year. The detailed AGIS research plan and Operations Manual are submitted with the Georgetown University lead application. The primary goal of the AGIS is to assess systematically the long- range outcomes of sequences of interventions in 840 eyes that have failed initial medical treatment of glaucoma. Eligible eyes will be randomly assigned to one of two intervention sequences; 1) trabeculectomy (T), followed by argon laser trabeculoplasty (ALT) should T fail, and followed by a second T should ALT fail; and 2) ALT followed by T should ALT fail, and followed by another T should the first T fail. Eyes that fail the assigned sequence of three interventions will be managed by additional surgery. The interventions will be supplemented with medical treatment as needed. We plan to follow all patients for five years to determine degree of visual function loss, rates of failure of interventions and intervention sequences, rates of complications, and need for supplemental therapy. The prognostic value of ocular, systemic, personal, and social factors, including compliance, will be studied. Participating institutions will adhere to common, specified definitions, eligibility criteria, methods of measurement, as well as diagnostic, treatment, quality control, and administrative procedures. A Coordinating Center will collect, process, and analyze study data and coordinate study activities; a Policy and Treatment Effects Monitoring Board will supervise the conduct of the study.