This is an application for 4 1/2 years of support for the clinical center at The University of Virginia to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). The principal goal 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 425 plus eyes of 365 plus patients. Each eye has been randomly assigned to one of two intervention sequences: 1) trabeculectomy (T) followed by argon laser trabeculoplasty (ALT) should T fail and followed by a second T should ALT fail; 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 loss, 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, 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 data 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 38 eyes of 30 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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY006824-13
Application #
2888250
Study Section
Vision Research and Training Committee (VSN)
Project Start
1987-09-01
Project End
2002-08-31
Budget Start
1999-09-01
Budget End
2000-08-31
Support Year
13
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
Ederer, Fred; Gaasterland, Douglas A; Dally, Leonard G et al. (2004) The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results. Ophthalmology 111:651-64
Kim, Jonghyeon; Dally, Leonard G; Ederer, Fred et al. (2004) The Advanced Glaucoma Intervention Study (AGIS): 14. Distinguishing progression of glaucoma from visual field fluctuations. Ophthalmology 111:2109-16
AGIS Investigators (2002) The Advanced Glaucoma Intervention Study (AGIS): 12. Baseline risk factors for sustained loss of visual field and visual acuity in patients with advanced glaucoma. Am J Ophthalmol 134:499-512
AGIS Investigators (2002) The Advanced Glaucoma Intervention Study (AGIS): 11. Risk factors for failure of trabeculectomy and argon laser trabeculoplasty. Am J Ophthalmol 134:481-98
AGIS Investigators (2001) The Advanced Glaucoma Intervention Study (AGIS): 9. Comparison of glaucoma outcomes in black and white patients within treatment groups. Am J Ophthalmol 132:311-20
Gaasterland, D E; Blackwell, B; Dally, L G et al. (2001) The Advanced Glaucoma Intervention Study (AGIS): 10. Variability among academic glaucoma subspecialists in assessing optic disc notching. Trans Am Ophthalmol Soc 99:177-84; discussion 184-5
AGIS (Advanced Glaucoma Intervention Study) Investigators (2001) The Advanced Glaucoma Intervention Study: 8. Risk of cataract formation after trabeculectomy. Arch Ophthalmol 119:1771-9
(2000) The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol 130:429-40
(2000) The advanced glaucoma intervention study, 6: effect of cataract on visual field and visual acuity. The AGIS Investigators. Arch Ophthalmol 118:1639-52
Schwartz, A L; Van Veldhuisen, P C; Gaasterland, D E et al. (1999) The Advanced Glaucoma Intervention Study (AGIS): 5. Encapsulated bleb after initial trabeculectomy. Am J Ophthalmol 127:8-19

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