|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Asan Medical Center |
|---|---|
| Information provided by: | Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00300014 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Post Vitrectomy State Recurrent Diabetic Vitreous Hemorrhage |
Procedure: Intravitreal triamcinolone injection Procedure: Air-fluid exchange |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sun Young Lee, MD | 82-2-3010-3970 | sunylee@amc.seoul.kr |
| Contact: June-Gone Kim, MD | 82-2-3010-3673 | dropkim@dreamwiz.com |
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Sun Young Lee, MD 82-2-3010-3970 sunylee@amc.seoul.kr | |
| Contact: June-Gone Kim, MD 82-3010-3673 dropkim@dreamwiz.com | |
| Principal Investigator: | Sun Young Lee, MD | Asan Medical Center |
| Principal Investigator: | He Won Chung, MD | Asan Medical Center |
| Principal Investigator: | Young Hee Yoon, MD | Asan Medical Center |
| Principal Investigator: | June-Gone Kim, MD | Asan Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00300014 History of Changes |
| Other Study ID Numbers: | IVT in vitreous hemorrhage |
| Study First Received: | March 7, 2006 |
| Last Updated: | June 12, 2007 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
|
Post vitrectomy Recurrent diabetic vitreous hemorrhage Intravitreal triamcinolone injection |
|
Hemorrhage Vitreous Hemorrhage Pathologic Processes Eye Hemorrhage Eye Diseases Triamcinolone hexacetonide Triamcinolone Acetonide Triamcinolone Triamcinolone diacetate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
