Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300014
Status:
UNKNOWN
Last Update Posted:
2007-06-13
First Post:
2006-03-07
Brief Title:
Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
ComparativeRandomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
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:
The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment air-fluid exchange
Detailed Description:
Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy Despite measures to prevent and control this bleeding it can lead to air-fluid exchange in the office or to additional surgery in the operating room Air-fluid exchange does not result in clear vision immediately after the procedure and the patient has to maintain a face-down position Vitreous lavage a more invasive procedure performed in the operating room may give rise to complications such as iatrogenic retinal breaks incarcerations of vitreous in the sclerotomy sites retinal detachment rubeosis iridis neovascular glaucoma infective endophthalmitis and sympathetic ophthalmia In contrast IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery while avoiding the face-down position
We believe that the rapid clearing of vitreous hemorrhage results from as follows 1 triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood 2 direct vascular stabilizing effect may be induced 3 antiangiogenic effect may play a role
We believe that the rapid clearing of vitreous hemorrhage results from as follows 1 triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood 2 direct vascular stabilizing effect may be induced 3 antiangiogenic effect may play a role
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