COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

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The intent of this application is to document the ability of The New York Eye and Ear Infirmary to participate as an effective and productive Clinical Center in the proposed multicenter clinical trial, entitled "Collaborative Initial Glaucoma Treatment Study" (CIGTS). This study's purpose is to evaluate whether initial treatment of open-angle glaucoma is more effective by means of a stepped, medical regimen or by means of a surgical approach. The New York Eye and Ear Infirmary's Clinical Center will participate in the CIGTS by identifying and recruiting eligible patients, administering the treatment regimen as assigned by the CIGTS's Coordinating Center and as defined within the study's Manual of Operations, following and retaining study patients, recording and transferring study data to the Coordinating Center, and contributing to reports that will present the CIGTS results. Additional patients will be recruited by a Satellite Subcenter headquartered at Long Island Jewish Medical Center. This Center will in turn recruit from local ophthalmologists. Its overall functioning, coordination, management and follow-up will be supervised by The New York Eye and Ear Infirmary Clinical Center. This application describes the ability of The New York Eye and Ear Infirmary's Clinical Center to enroll approximately 50 patients per year, based upon pilot studies of patient eligibility conducted during a 3 month period. The Satellite Subcenter is expected to enroll approximately 15 to 20 patients per year. Details are provided of our plans to identify, recruit, follow, and retain these patients, our intent to obtain consistently high quality data on the visual outcomes of treatment, and the personnel and facilities available within our center to carry out the provisions of the CIGTS's Manual of Operations.