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Trial NCT00000131

Resource URI: http://static.linkedct.org/resource/trials/NCT00000131
linkedct:brief_title Central Vein Occlusion Study (CVOS)
linkedct:condition <http://static.linkedct.org/resource/condition/11557>
linkedct:condition <http://static.linkedct.org/resource/condition/11569>
linkedct:criteria Men and women must have been age 21 or older and willing to return for followup visits for 3 years following assignment into the appropriate group and randomization. Each of the four groups has specific eligibility criteria. Patients with retinal vascular disease other than that specified in the criteria, such as diabetic retinopathy, were ineligible. Patients with macular disease other than that due to CVO were ineligible for that portion of the study.
linkedct:description Central vein occlusion is a common retinal vascular disorder with potentially blinding complications. The two major complications are reduced central vision caused by macular edema and neovascular glaucoma caused by iris neovascularization. Other clinical trials have shown that laser photocoagulation is an effective treatment for complications found in diabetic retinopathy and branch vein occlusion, which have some features in common with CVO: neovascularization and reduced visual acuity caused by macular edema occur in all three disorders. Evidence from small-scale studies suggests that a grid pattern of photocoagulation reduces macular edema in CVO patients, although the associated changes in visual acuity are variable. The CVOS is a detailed investigation of grid pattern photocoagulation in a larger randomized group of patients. Eligible patients were divided into four groups: Group N: Eyes with extensive retinal ischemia (at least 10 disc areas of nonperfusion) were randomly assigned to receive panretinal photocoagulation or nontreatment unless iris neovascularization developed. Group M: Eyes with visual loss ascribable to macular edema were randomly assigned to receive grid-pattern photocoagulation or nontreatment. Group P: Eyes with relatively perfused retinas were followed to provide information about the natural history of the disease. Group I: Indeterminate eyes in which the retina could not be visualized accurately because of hemorrhage were followed in a natural history study. Green argon laser with a slit lamp delivery system was used for all treatments. Photographic documentation of retinal changes was obtained at entry, post-treatment, and at specified followup visits for a period of at least 3 years. The frequency of followup visits varied according to the group to which the CVO patient was assigned. Visual acuity, the primary outcome factor in the group with macular edema, was measured according to a modified Early Treatment Diabetic Retinopathy Study protocol at each visit.
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 21 Years
linkedct:end_date February 1994
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000131
rdfs:label Trial NCT00000131
linkedct:lastchanged_date September 16, 2009
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:nct_id NCT00000131
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-30
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000131>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/45009>
linkedct:reference <http://static.linkedct.org/resource/reference/45745>
linkedct:reference <http://static.linkedct.org/resource/reference/51929>
linkedct:reference <http://static.linkedct.org/resource/reference/51930>
linkedct:reference <http://static.linkedct.org/resource/reference/52003>
linkedct:source National Eye Institute (NEI)
linkedct:start_date August 1988
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To determine whether photocoagulation therapy can help prevent iris neovascularization in eyes with central vein occlusion (CVO) and evidence of ischemic retina. To assess whether grid-pattern photocoagulation therapy will reduce loss of central visual acuity due to macular edema secondary to CVO. To develop new data describing the course and prognosis for eyes with CVO.
rdf:type linkedct:trials
linkedct:verification_date September 2009