Completed

Central Vein Occlusion Study (CVOS)

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What is being tested

Photocoagulation Therapy

Procedure
Who is being recruted

Retinal Vein Occlusion

+ Retinal Diseases
Over 21 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1988

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: September 17, 2009
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1988Actual date on which the first participant was enrolled.

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. 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.

Official TitleCentral Vein Occlusion Study (CVOS) 
Principal SponsorNational Eye Institute (NEI)
Last updated: September 17, 2009
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Retinal Vein Occlusion
Retinal Diseases
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

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CompletedNo study centers