We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advanced Glaucoma Intervention Study (AGIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2003 by National Eye Institute (NEI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000148
First Posted: September 24, 1999
Last Update Posted: June 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Eye Institute (NEI)
  Purpose
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.

Condition Intervention Phase
Glaucoma Procedure: Argon Laser Trabeculoplasty Procedure: Trabeculectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: April 1988
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000148


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000148     History of Changes
Other Study ID Numbers: NEI-49
First Submitted: September 23, 1999
First Posted: September 24, 1999
Last Update Posted: June 5, 2006
Last Verified: October 2003

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases