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	Treatment or Intervention	Phase
Glaucoma	Procedure: Argon Laser Trabeculoplasty  Procedure: Trabeculectomy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  35 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

Connecticut
      Yale University School of Medicine, Yale Eye Center, New Haven,  Connecticut,  United States
District of Columbia
      Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C., Washington,  District of Columbia,  United States
Georgia
      Emory University, Emory Eye Center, Atlanta,  Georgia,  United States
      Piedmont Hospital, Eye Consultants of Atlanta, Atlanta,  Georgia,  United States
Illinois
      University of Illinois, Eye and Ear Infirmary, Chicago,  Illinois,  United States
      Humana Health Plan Sykes Center, Chicago,  Illinois,  United States
Maryland
      Washington Hospital Center, Washington Eye Physicians and Surgeons, Chevy Chase,  Maryland,  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
Ohio
      Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants, Columbus,  Ohio,  United States
Pennsylvania
      Wills Eye Hospital, Glaucoma Service, Philadelphia,  Pennsylvania,  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

Study ID Numbers:  NEI-49
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  September 23, 1999
ClinicalTrials.gov Identifier:  NCT00000148
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08