Paul R. Lichter, MD - US grants

This is an application for 4 1/2 years of support for the clinical center at the University of Michigan to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). The principal goat of AGIS is to assess systematically the long-range outcomes of sequences of interventions in eyes with primary open-angle glaucoma that have failed initial medical treatment. Between April 1, 1988 and March 31, 1991 AGIS has enrolled 575 eyes of 435 patients. Each eye has been randomly assigned to one of two intervention sequences: i) trabeculectomy (T) followed by argon Laser trabeculoplasty (ALT) should T fail and followed by a second T should ALT fait; and 2) ALT followed by T should ALT fail and followed by another T should the first T fail. The interventions are supplemented with medical treatment as needed. As of March 31, 1991 follow-up ranged from 0 to 36 months. Less than five percent of follow-up exams, scheduled at 6-month intervals, have been missed. Data are being collected on visual function. toss, intervention failure, complications, need for supplemental medical therapy, compliance with medical therapy, and quality of Life. The prognostic values of ocular and non-ocular medical factors and personal factors are being studied. The study plans 1) to continue patient recruitment until 790 eyes are enrolled, a goal that is expected to be reached between April 1 and November 30, 1992, and 2) to continue patient follow-up until November 30, 1996, so that follow-up will ultimately range from a minimum of 4 to 4 2/3 years to a maximum of 8 2/3 years. A coordinating center collects, processes, and analyzes study date and coordinates study activities. A Policy and Treatment Effects Monitoring Board supervises the conduct of the study and monitors study outcomes. Submitted with the Georgetown University Lead application are: 1) the AGIS research plan, detailing study rationale, design and methods, 2) the plans for continued patient recruitment and follow-up, and 3) study accomplishments to date, including examples of data analyses. Between April 1, 1988 and March 31, 1991 this clinical center has enrolled 46 eyes of 35 patients. The present application details the qualifications of this clinical center for continued participation, including our ability to recruit and retain patients and to adhere to the study definitions, criteria, and procedures.

The Core Grant for Vision Research at the University of Michigan. supports four modules: 1) A Machine Shop Module for designing and constructing mechanical instrumentation, staffed by an instrument maker; 2) an Electronics Shop Module for the designing and constructing of electronics equipment, staffed by an electrical engineer and an electronics technician; 3) a Morphology and Imaging Module for the processing of ocular tissue for light and electron microscopy, immunohistochemistry and in situ hybridization, as well as the production of black and white photographs and digital images, staffed by a technician; and, 4) a Vivarium Module for the housing and care of laboratory animals used in vision research, staffed by a veterinary technician. The specific aims of the Core Grant for Vision Research at the University of Michigan are to enhance the research environment for vision scientists, facilitate collaborative studies of the visual system and its diseases, and expand vision research on this campus to bring the skill and perspective of non-vision scientists to bear upon research issues of the visual system. The 19 participating investigators of the Core currently hold 15 NEI grants, with 2 additional grant applications pending. The research interests of these investigators are diverse and include electrophysiology, neurobiology, biochemistry, molecular biology, molecular genetics, immunology, and clinical ophthalmology. The Core Grant will be housed within the W.K. Kellogg Eye Center, a 120,000 sq. ft. building containing space dedicated to each of the modules, plus state-of-the-art facilities for basic and clinical research.