Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
Primary Purpose
Proliferative Vitreoretinopathy
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Vitreoretinopathy focused on measuring PVR, Retinal detachment, Silicone oil, Triamcinolone
Eligibility Criteria
Inclusion Criteria:
- Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.
Exclusion Criteria:
- History of trauma
- Presence of diabetic retinopathy
- History of vein occlusion
- Giant retinal tear
Sites / Locations
- Hamid Ahmadieh,MD
Outcomes
Primary Outcome Measures
Single-operation retinal reattachment rate six
months after surgery.
Secondary Outcome Measures
Visual acuity
Retinal reproliferation
Intraocular pressure
Early silicone oil emulsification
Full Information
NCT ID
NCT00373282
First Posted
September 7, 2006
Last Updated
October 11, 2006
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00373282
Brief Title
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy
Keywords
PVR, Retinal detachment, Silicone oil, Triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Primary Outcome Measure Information:
Title
Single-operation retinal reattachment rate six
Title
months after surgery.
Secondary Outcome Measure Information:
Title
Visual acuity
Title
Retinal reproliferation
Title
Intraocular pressure
Title
Early silicone oil emulsification
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.
Exclusion Criteria:
History of trauma
Presence of diabetic retinopathy
History of vein occlusion
Giant retinal tear
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh,MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
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