The intent of this application is to document the ability of Wake Forest University 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 Wake Forest University'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. This application describes the ability of the Wake Forest University's Clinical Center to enroll approximately 36 patients per year, based upon pilot studies of patient eligibility conducted during a three month period. 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 Operation.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY009639-02
Application #
2163320
Study Section
Vision Research and Training Committee (VSN)
Project Start
1993-07-01
Project End
1998-06-30
Budget Start
1994-07-01
Budget End
1995-06-30
Support Year
2
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Surgery
Type
Schools of Medicine
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
Zahid, Sarwar; Musch, David C; Niziol, Leslie M et al. (2013) Risk of endophthalmitis and other long-term complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Am J Ophthalmol 155:674-680, 680.e1
Chen, Philip P; Musch, David C; Niziol, Leslie M (2011) The effect of early posttrabeculectomy intraocular pressure spike in the collaborative initial glaucoma treatment study. J Glaucoma 20:211-4
Musch, David C; Gillespie, Brenda W; Lichter, Paul R et al. (2009) Visual field progression in the Collaborative Initial Glaucoma Treatment Study the impact of treatment and other baseline factors. Ophthalmology 116:200-7
Jampel, Henry D; Musch, David C; Gillespie, Brenda W et al. (2005) Perioperative complications of trabeculectomy in the collaborative initial glaucoma treatment study (CIGTS). Am J Ophthalmol 140:16-22
Gillespie, Brenda W; Musch, David C; Guire, Kenneth E et al. (2003) The collaborative initial glaucoma treatment study: baseline visual field and test-retest variability. Invest Ophthalmol Vis Sci 44:2613-20
Mills, R P; Janz, N K; Wren, P A et al. (2001) Correlation of visual field with quality-of-life measures at diagnosis in the Collaborative Initial Glaucoma Treatment Study (CIGTS). J Glaucoma 10:192-8
Janz, N K; Wren, P A; Lichter, P R et al. (2001) The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology 108:1954-65
Janz, N K; Wren, P A; Lichter, P R et al. (2001) Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Ophthalmology 108:887-97; discussion 898
Lichter, P R; Musch, D C; Gillespie, B W et al. (2001) Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 108:1943-53