Advanced Glaucoma Intervention Study (AGIS). Manual of Operations

摘要

The manual of operations details the rationale, objectives, designs, organizations, policies, and methods of the Advanced Glaucoma Intervention Study (AGIS), in which eleven clinical centers and a coordinating center are collaborating. The primary purpose of the study is to provide a comprehensive assessment of long-range outcomes of two intervention sequences in adults with open-angle glaucoma who have failed medical treatment. Between 1988 and 1992, seven hundred and eighty-nine eyes in 591 patients were randomly assigned to one of the following two intervention sequences: (1) Trabeculectomy, followed by argon laser trabeculoplasty (ALT) after trabeculectomy has failed, followed by another trabeculectomy after ALT has failed; (2) ALT, followed by trabeculectomy after ALT has failed, followed by a second trabeculectomy after the first trabeculectomy has failed. The eyes and patients are being followed under a standardized protocol for at least four and a half years to determine time-specific rates of loss of visual function and rates of failure of the intervention programs. AGIS also seeks to answer specific questions about the efficacy of the intervention strategies for these patients.