Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000131
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Central Vein Occlusion Study CVOS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None