Central Vein Occlusion Study (CVOS)
Primary Purpose
Retinal Vein Occlusion, Retinal Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Photocoagulation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring Central Vein Occlusion, Ischemic Retina
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000131
First Posted
September 23, 1999
Last Updated
September 16, 2009
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00000131
Brief Title
Central Vein Occlusion Study (CVOS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Retinal Diseases
Keywords
Central Vein Occlusion, Ischemic Retina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Photocoagulation Therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
7688950
Citation
Baseline and early natural history report. The Central Vein Occlusion Study. Arch Ophthalmol. 1993 Aug;111(8):1087-95. doi: 10.1001/archopht.1993.01090080083022.
Results Reference
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PubMed Identifier
7533959
Citation
Clarkson JG. Central Vein Occlusion Study: photographic protocol and early natural history. Trans Am Ophthalmol Soc. 1994;92:203-13; discussion 213-5. No abstract available.
Results Reference
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PubMed Identifier
9097788
Citation
Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4.
Results Reference
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PubMed Identifier
9097789
Citation
A randomized clinical trial of early panretinal photocoagulation for ischemic central vein occlusion. The Central Vein Occlusion Study Group N report. Ophthalmology. 1995 Oct;102(10):1434-44.
Results Reference
background
PubMed Identifier
9109757
Citation
Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006. Erratum In: Arch Ophthalmol 1997 Oct;115(10):1275.
Results Reference
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Central Vein Occlusion Study (CVOS)
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