COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

点击翻译按钮获取中文摘要

The intent of this application is to document the ability of the Albany Medical College, Department of Ophthalmology 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, medial regimen or by means of a surgical approach. The Albany Medical College'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 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. As a clinical center in the Collaborative Initial Glaucoma Treatment Study, the Glaucoma Service at the Albany Medical College, Department of Ophthalmology, Lions Eye Institute, offers a state of the art clinical research facility for the diagnosis and treatment of glaucoma. The three investigators have extensive experience in glaucoma research and have large consultative practices specializing in glaucoma ( greater than 15, 000 glaucoma patient visits /year) . In addition, 26 community board certified ophthalmologists have enrolled to actively participate with this center in the study. As a group, they offer a large clinical base in Northeastern New York ( greater than 150,000 patient visits/year) which maximizes patient recruitment and care. In a 3 month trial recruitment for this study using the criteria outlined in the Manual of Operations, this center identified 18 qualifying patients, representing adequate potential for patient recruitment (Appendix 1). This center expects to recruit 3 patients per month for participation in this study. The study population will include both sexes and patients of a variety of ethnic and racial backgrounds consistent with this geographical region of the country. 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.