Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Post Vitrectomy State
Intervention
Intravitreal triamcinolone injection, Air-fluid exchange
Location
Asan Medical Center
Seoul
Korea, Republic of
138-736
Status
Recruiting
Source
Asan Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00300014
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Triamcinolone Acetonide
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
Triamcinolone
A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739)
Ion Exchange
Reversible chemical reaction between a solid, often one of the ION EXCHANGE RESINS, and a fluid whereby ions may be exchanged from one substance to another. This technique is used in water purification, in research, and in industry.
Microinjections
The injection of very small amounts of fluid, often with the aid of a microscope and microsyringes.
Ion Exchange Resins
High molecular weight, insoluble polymers which contain functional groups that are capable of undergoing exchange reactions (ION EXCHANGE) with either cations or anions.
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