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Trial NCT00000162

Resource URI: http://static.linkedct.org/resource/trials/NCT00000162
linkedct:brief_title Branch Vein Occlusion Study
linkedct:condition <http://static.linkedct.org/resource/condition/13861>
linkedct:condition <http://static.linkedct.org/resource/condition/7633>
linkedct:condition <http://static.linkedct.org/resource/condition/8683>
linkedct:criteria Patients with three types of diagnoses were accepted: 1. major BVO without neovascularization; 2. major BVO with neovascularization; 3. BVO with macular edema and reduced vision. All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.
linkedct:description Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none were proven to be effective. The only treatment that seemed at all promising in preventing visual loss from BVO was laser photocoagulation. Approximately 500 patients were enrolled in the study. One-half were randomly assigned to treatment with argon laser photocoagulation; the other one-half remained untreated as controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser burns was applied in the drainage area of the occluded vein site, avoiding the fovea and optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old had to have been available for each patient. Treatment was performed under topical anesthesia using the argon laser to achieve a grid pattern over the area of capillary leakage identified by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea than the edge of the foveal avascular zone and did not extend peripherally beyond the major vascular arcade. The efficacy of treatment was judged on the basis of visual acuity measurements as well as assessment of the subsequent development of neovascularization and/or vitreous hemorrhage. Patients were followed for at least 3 years.
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 N/A
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000162
rdfs:label Trial NCT00000162
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:nct_id NCT00000162
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-64
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000162>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/39076>
linkedct:reference <http://static.linkedct.org/resource/reference/43368>
linkedct:source National Eye Institute (NEI)
linkedct:start_date July 1977
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To determine whether scatter argon laser photocoagulation can prevent the development of neovascularization. To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous hemorrhage. To determine whether macular argon laser photocoagulation can improve visual acuity in eyes with macular edema reducing vision to 20/40 or worse.
rdf:type linkedct:trials
linkedct:verification_date October 1999