Comparison of Trabeculectomy and Argon Laser Trabeculoplasty Sequences in Advanced Glaucoma Management
Data Collection
Eye Diseases
+ Glaucoma
+ Ocular Hypertension
Treatment Study
Summary
Study start date: April 1, 1988
Actual date on which the first participant was enrolled.The Advanced Glaucoma Intervention Study (AGIS) focuses on managing advanced glaucoma, a condition where medication alone can't lower eye pressure adequately, causing vision loss. Before 1980, a surgical procedure called trabeculectomy was commonly used. However, laser trabeculoplasty has gained popularity since then. The study aims to understand which sequence of these interventions yields the best long-term results, as success varies and some patients may need multiple procedures over time. The study involves individuals with advanced glaucoma, comparing two intervention sequences to manage the disease. Participants are randomly assigned to one of two sequences: either starting with trabeculectomy, followed by argon laser trabeculoplasty (ALT) if the first procedure fails, then a second trabeculectomy if ALT fails; or starting with ALT, followed by trabeculectomy if ALT fails, then another trabeculectomy if the first one fails. These interventions are supplemented with medication as needed. The study follows all patients for at least 5 years, scheduling regular examinations to evaluate visual function loss, intervention failure rates, complication rates, and the need for additional therapy. The primary outcome is the percentage of eyes with decreased vision, while secondary outcomes include sustained vision loss, intervention failures, number of prescribed glaucoma medications, and eye pressure levels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 35 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Yale University School of Medicine, Yale Eye Center
New Haven, United StatesOpen Yale University School of Medicine, Yale Eye Center in Google MapsGeorgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., United StatesEmory University, Emory Eye Center
Atlanta, United StatesPiedmont Hospital, Eye Consultants of Atlanta
Atlanta, United States