Central Vein Occlusion Study (CVOS)
Sponsor: National Eye Institute (NEI)
Listed as NCT00000131, this PHASE3 trial focuses on Retinal Diseases and Retinal Vein Occlusion and remains completed. Sponsored by National Eye Institute (NEI), it has been updated 6 times since 1988, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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...
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2024 — Present [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Aug 1988
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Eye Institute (NEI)
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.