Advanced Glaucoma Intervention Study (AGIS)

June 2, 2006 updated by: National Eye Institute (NEI)
To assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.

Study Overview

Status

Unknown

Conditions

Detailed Description

In advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and the eye has field defects. Before 1980, some type of filtering surgery, such as trabeculectomy, was the usual method of intervention. Since then, laser trabeculoplasty has become a popular alternative. Sometimes the first intervention chosen succeeds in controlling pressure for many years; at other times, the success lasts only a few weeks or months. Because success is limited, some patients, over time, need to undergo a sequence of surgical interventions. Little is known about which sequence gives the best long-range outcome.

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University School of Medicine, Yale Eye Center
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University, Emory Eye Center
      • Atlanta, Georgia, United States
        • Piedmont Hospital, Eye Consultants of Atlanta
    • Illinois
      • Chicago, Illinois, United States
        • Humana Health Plan Sykes Center
      • Chicago, Illinois, United States
        • University of Illinois, Eye and Ear Infirmary
    • Maryland
      • Chevy Chase, Maryland, United States
        • Washington Hospital Center, Washington Eye Physicians and Surgeons
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan, W.K. Kellogg Eye Center
      • Southfield, Michigan, United States
        • Sinai Hospital, Detroit, Franklin Eye Consultants
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Wills Eye Hospital, Glaucoma Service
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia Medical Center, Department of Ophthalmology
      • Richmond, Virginia, United States
        • Medical College of Virginia, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1988

Study Registration Dates

First Submitted

September 23, 1999

First Submitted That Met QC Criteria

September 23, 1999

First Posted (ESTIMATE)

September 24, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2006

Last Update Submitted That Met QC Criteria

June 2, 2006

Last Verified

October 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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