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Trial NCT00000148

Resource URI: http://static.linkedct.org/resource/trials/NCT00000148
PropertyValue
linkedct:brief_title Advanced Glaucoma Intervention Study (AGIS)
linkedct:condition <http://static.linkedct.org/resource/condition/5287>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000148
rdfs:label Trial NCT00000148
linkedct:lastchanged_date June 2, 2006
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:location <http://static.linkedct.org/resource/location/135740>
linkedct:location <http://static.linkedct.org/resource/location/135897>
linkedct:location <http://static.linkedct.org/resource/location/137191>
linkedct:location <http://static.linkedct.org/resource/location/137229>
linkedct:location <http://static.linkedct.org/resource/location/137706>
linkedct:location <http://static.linkedct.org/resource/location/137769>
linkedct:location <http://static.linkedct.org/resource/location/139175>
linkedct:location <http://static.linkedct.org/resource/location/139723>
linkedct:location <http://static.linkedct.org/resource/location/140018>
linkedct:location <http://static.linkedct.org/resource/location/143020>
linkedct:location <http://static.linkedct.org/resource/location/144035>
linkedct:location <http://static.linkedct.org/resource/location/145936>
linkedct:location <http://static.linkedct.org/resource/location/146127>
linkedct:nct_id NCT00000148
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-49
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000148>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/3385>
linkedct:reference <http://static.linkedct.org/resource/reference/45983>
linkedct:reference <http://static.linkedct.org/resource/reference/46881>
linkedct:reference <http://static.linkedct.org/resource/reference/54689>
linkedct:reference <http://static.linkedct.org/resource/reference/54690>
linkedct:source National Eye Institute (NEI)
linkedct:start_date April 1988
linkedct:study_design Treatment, Randomized, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date October 2003