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Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00300014
Collaborator
(none)
30
Enrollment
1
Location
15.9
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intravitreal triamcinolone injection
  • Procedure: Air-fluid exchange
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jan 1, 2006
Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. day 1 : intraocular pressure, biomicroscope exam, fundus exam []

  2. day 7 : intraocular pressure, biomicroscope exam, fundus exam []

  3. 2 weeks : intraocular pressure, biomicroscope exam, fundus exam []

  4. 4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography []

  5. 2 months : intraocular pressure, biomicroscope exam, fundus exam []

  6. 3months : intraocular pressure, biomicroscope exam, fundus exam []

  7. 6 months : intraocular pressure, biomicroscope exam, fundus exam []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Previous vitrectomy due to proliferative diabetic retinopathy

  • Recurrent diabetic vitreous hemorrhage

Exclusion Criteria:

  • Monocular vision

  • Uncontrollable intraocular pressure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 138-736

Sponsors and Collaborators

  • Asan Medical Center

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00300014
Other Study ID Numbers:
  • IVT in vitreous hemorrhage
First Posted:
Mar 8, 2006
Last Update Posted:
Jun 13, 2007
Last Verified:
Jun 1, 2007
Keywords provided by , ,
Post vitrectomy
Recurrent diabetic vitreous hemorrhage
Intravitreal triamcinolone injection
Additional relevant MeSH terms:
Vitreous Hemorrhage
Hemorrhage
Triamcinolone

Study Results

No Results Posted as of Jun 13, 2007