|
Advanced Glaucoma Intervention Study (AGIS) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Advanced Glaucoma Intervention Study (AGIS) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Advanced Glaucoma Intervention Study (AGIS) Clinical research trials and Advanced Glaucoma Intervention Study (AGIS) medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Advanced Glaucoma Intervention Study (AGIS). Advanced Glaucoma Intervention Study (AGIS) Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Advanced Glaucoma Intervention Study (AGIS) clinical trial. Participants frequently obtain the most expert healthcare available for their Advanced Glaucoma Intervention Study (AGIS) condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Advanced Glaucoma Intervention Study (AGIS)  Advanced Glaucoma Intervention Study (AGIS)
Advanced Glaucoma Intervention Study (AGIS)
For Condition: Glaucoma
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Efficacy Study
Minimum Age/Maximum Age: 35 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
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
Washington Hospital Center, Washington Eye Physicians and Surgeons
Chevy Chase, Maryland,
United States
Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., District of Columbia,
United States
Yale University School of Medicine, Yale Eye Center
New Haven, Connecticut,
United States
University of Michigan, W.K. Kellogg Eye Center
Ann Arbor, Michigan,
United States
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania,
United States
University of Illinois, Eye and Ear Infirmary
Chicago, Illinois,
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
Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
Columbus, Ohio,
United States
Sinai Hospital, Detroit, Franklin Eye Consultants
Southfield, Michigan,
United States
Additional Information:
Study ID Numbers: NEI-49;
Study Start Date: April 1988
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000148
Other Glaucoma Studies:
1. Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients with Glaucoma or Ocular Hypertension.
2. Cause of Pigment Dispersion Syndrome
3. Mechanism of Action of TRAVATAN 0.004% in Subjects with Glaucoma or Ocular Hypertension
4. Advanced Glaucoma Intervention Study (AGIS)
5. Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients with Glaucoma or Ocular Hypertension
Related Studies:
Other Glaucoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Advanced Glaucoma Intervention Study (AGIS)
|
|
|
|
|
|
|
|
