Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
1988-04-30
Brief Summary
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Detailed Description
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The Advanced Glaucoma Intervention Study (AGIS) is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma. The study uses visual function status to compare two intervention sequences in managing the disease.
Eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy, followed by argon laser trabeculoplasty (ALT) should trabeculectomy fail, followed by a second trabeculectomy should ALT fail; or (2) ALT, followed by trabeculectomy should ALT fail, followed by another trabeculectomy should the first trabeculectomy fail. Antifibrotic agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history of invasive surgery. Eyes that fail the entire assigned sequence of interventions are managed at the discretion of the AGIS physician in collaboration with the patient.
Interventions are supplemented with medical treatment as needed. A total of 789 eyes with advanced glaucoma have been enrolled. All patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss, failure rates of interventions, rates of complications, and need for supplemental therapy.
After the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3 months, 6 months, and every 6 months thereafter. After second and third interventions, followup examinations are scheduled at 1 and 4 weeks. Additional visits are scheduled as necessary for the management of the disease.
The primary outcome variable in AGIS is average percent of eyes with decrease of vision, where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma. Secondary outcome variables include sustained decrease of vision, failure of interventions, number of prescribed glaucoma medications, and level of intraocular pressure. An ancillary study is assessing filtering bleb encapsulation.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Argon Laser Trabeculoplasty
Trabeculectomy
Eligibility Criteria
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Inclusion Criteria
35 Years
80 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Locations
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Yale University School of Medicine, Yale Eye Center
New Haven, Connecticut, United States
Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., District of Columbia, United States
Emory University, Emory Eye Center
Atlanta, Georgia, United States
Piedmont Hospital, Eye Consultants of Atlanta
Atlanta, Georgia, United States
Humana Health Plan Sykes Center
Chicago, Illinois, United States
University of Illinois, Eye and Ear Infirmary
Chicago, Illinois, United States
Washington Hospital Center, Washington Eye Physicians and Surgeons
Chevy Chase, Maryland, United States
University of Michigan, W.K. Kellogg Eye Center
Ann Arbor, Michigan, United States
Sinai Hospital, Detroit, Franklin Eye Consultants
Southfield, Michigan, United States
Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
Columbus, Ohio, United States
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania, United States
University of Virginia Medical Center, Department of Ophthalmology
Charlottesville, Virginia, United States
Medical College of Virginia, Department of Ophthalmology
Richmond, Virginia, United States
Countries
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References
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The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192
Ederer F, Gaasterland DE, Sullivan EK; AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994 Aug;15(4):299-325. doi: 10.1016/0197-2456(94)90046-9.
Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120
The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. doi: 10.1016/s0161-6420(98)97012-9.
The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. doi: 10.1016/s0161-6420(98)97013-0.
Caprioli J, Mock D, Bitrian E, Afifi AA, Yu F, Nouri-Mahdavi K, Coleman AL. A method to measure and predict rates of regional visual field decay in glaucoma. Invest Ophthalmol Vis Sci. 2011 Jul 1;52(7):4765-73. doi: 10.1167/iovs.10-6414.
Other Identifiers
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NEI-49
Identifier Type: -
Identifier Source: org_study_id