Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Primary Purpose
Post Vitrectomy State, Recurrent Diabetic Vitreous Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal triamcinolone injection
Air-fluid exchange
Sponsored by
About this trial
This is an interventional treatment trial for Post Vitrectomy State focused on measuring Post vitrectomy, Recurrent diabetic vitreous hemorrhage, Intravitreal triamcinolone injection
Eligibility Criteria
Inclusion Criteria: Previous vitrectomy due to proliferative diabetic retinopathy Recurrent diabetic vitreous hemorrhage Exclusion Criteria: Monocular vision Uncontrollable intraocular pressure
Sites / Locations
- Asan Medical CenterRecruiting
Outcomes
Primary Outcome Measures
day 1 : intraocular pressure, biomicroscope exam, fundus exam
day 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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00300014
Brief Title
Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Official Title
Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Vitrectomy State, Recurrent Diabetic Vitreous Hemorrhage
Keywords
Post vitrectomy, Recurrent diabetic vitreous hemorrhage, Intravitreal triamcinolone injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intravitreal triamcinolone injection
Intervention Type
Procedure
Intervention Name(s)
Air-fluid exchange
Primary Outcome Measure Information:
Title
day 1 : intraocular pressure, biomicroscope exam, fundus exam
Title
day 7 : intraocular pressure, biomicroscope exam, fundus exam
Title
2 weeks : intraocular pressure, biomicroscope exam, fundus exam
Title
4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
Title
2 months : intraocular pressure, biomicroscope exam, fundus exam
Title
3months : intraocular pressure, biomicroscope exam, fundus exam
Title
6 months : intraocular pressure, biomicroscope exam, fundus exam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous vitrectomy due to proliferative diabetic retinopathy
Recurrent diabetic vitreous hemorrhage
Exclusion Criteria:
Monocular vision
Uncontrollable intraocular pressure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Young Lee, MD
Phone
82-2-3010-3970
Email
sunylee@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
June-Gone Kim, MD
Phone
82-2-3010-3673
Email
dropkim@dreamwiz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Young Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
He Won Chung, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
June-Gone Kim, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Young Lee, MD
Phone
82-2-3010-3970
Email
sunylee@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
June-Gone Kim, MD
Phone
82-3010-3673
Email
dropkim@dreamwiz.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
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