Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000154
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Diabetic Retinopathy Vitrectomy Study DRVS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-10
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 compare two therapies early vitrectomy and conventional management for recent severe vitreous hemorrhage secondary to diabetic retinopathy Conventional management includes vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if retinal detachment involving the center of the macula develops at any time
To compare early vitrectomy and conventional management in eyes that have good vision but a poor prognosis because they are threatened with hemorrhage or retinal detachment from very severe proliferative retinopathy
To study the natural history of severe proliferative diabetic retinopathy
To compare early vitrectomy and conventional management in eyes that have good vision but a poor prognosis because they are threatened with hemorrhage or retinal detachment from very severe proliferative retinopathy
To study the natural history of severe proliferative diabetic retinopathy
Detailed Description:
Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on the retina from contraction of the fibrovascular membranes that characterize severe proliferative diabetic retinopathy It is important to determine whether early intervention with vitrectomy has a better visual outcome or instead produces a rate of serious complications higher than the rate associated with conventional management
Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had either insulin-dependent or non-insulin-dependent diabetes In the first trial the 616 patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in at least one eye Eligible eyes were randomly assigned either to early vitrectomy or to conventional management In the conventional management group vitrectomy was carried out 1 year later if hemorrhage persisted vitrectomy was carried out sooner if retinal detachment -involving the center of the macula occurred
In the second trial 381 patients were recruited all of whom had severe fibrovascular proliferations and useful vision in at least one eye Eligible eyes were assigned either to early vitrectomy or to conventional management Conventional management included photocoagulation when indicated with vitrectomy if a severe vitreous hemorrhage occurred and failed to clear spontaneously during a 6-month waiting period or if retinal detachment involving the center of the macula -occurred After randomization and treatment all patients were examined at 6-month intervals for 2 years and annually thereafter Comparisons of visual acuity distributions between experimental and control groups were made
Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had either insulin-dependent or non-insulin-dependent diabetes In the first trial the 616 patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in at least one eye Eligible eyes were randomly assigned either to early vitrectomy or to conventional management In the conventional management group vitrectomy was carried out 1 year later if hemorrhage persisted vitrectomy was carried out sooner if retinal detachment -involving the center of the macula occurred
In the second trial 381 patients were recruited all of whom had severe fibrovascular proliferations and useful vision in at least one eye Eligible eyes were assigned either to early vitrectomy or to conventional management Conventional management included photocoagulation when indicated with vitrectomy if a severe vitreous hemorrhage occurred and failed to clear spontaneously during a 6-month waiting period or if retinal detachment involving the center of the macula -occurred After randomization and treatment all patients were examined at 6-month intervals for 2 years and annually thereafter Comparisons of visual acuity distributions between experimental and control groups were made
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