Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Vitrectomy State; Recurrent Diabetic Vitreous Hemorrhage
Intervention: Intravitreal triamcinolone injection (Procedure); Air-fluid exchange (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Sun Young Lee, MD, Principal Investigator, Affiliation: Asan Medical Center
He Won Chung, MD, Principal Investigator, Affiliation: Asan Medical Center
Young Hee Yoon, MD, Principal Investigator, Affiliation: Asan Medical Center
June-Gone Kim, MD, Principal Investigator, Affiliation: Asan Medical Center
Overall contact:
Sun Young Lee, MD, Phone: 82-2-3010-3970, Email: sunylee@amc.seoul.kr
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.
Clinical Details
Official title: Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: day 1 : intraocular pressure, biomicroscope exam, fundus examday 7 : intraocular pressure, biomicroscope exam, fundus exam 2 weeks : intraocular pressure, biomicroscope exam, fundus exam 4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography 2 months : intraocular pressure, biomicroscope exam, fundus exam 3months : intraocular pressure, biomicroscope exam, fundus exam 6 months : intraocular pressure, biomicroscope exam, fundus exam
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Previous vitrectomy due to proliferative diabetic retinopathy
- Recurrent diabetic vitreous hemorrhage
Exclusion Criteria:
- Monocular vision
- Uncontrollable intraocular pressure
Locations and Contacts
Sun Young Lee, MD, Phone: 82-2-3010-3970, Email: sunylee@amc.seoul.kr
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Sun Young Lee, MD, Phone: 82-2-3010-3970, Email: sunylee@amc.seoul.kr
June-Gone Kim, MD, Phone: 82-3010-3673, Email: dropkim@dreamwiz.com
Additional Information
Starting date: January 2006
Ending date: May 2007
Last updated: June 12, 2007
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