Back to resultsThe Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
Primary Purpose
Proliferative Vitreoretinopathy
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
low molecular weight heparin, 5-FU
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Vitreoretinopathy focused on measuring silicone oil, PVR, retinal redetachment, low molecular weight heparin, 5-FU
Eligibility Criteria
Inclusion Criteria: Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal Exclusion Criteria: any sign of retinal redetachment before silicone oil removal any sign of diabetic retinopathy
Sites / Locations
- Hamid Ahmadieh, MD
Outcomes
Primary Outcome Measures
Retinal redetachment rate
Secondary Outcome Measures
visual acuity
intraocular pressure
reoperation
relative afferent pupillary defect
Full Information
NCT ID
NCT00371020
First Posted
August 31, 2006
Last Updated
July 11, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00371020
Brief Title
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Anticipated)
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 combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy
Keywords
silicone oil, PVR, retinal redetachment, low molecular weight heparin, 5-FU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin, 5-FU
Primary Outcome Measure Information:
Title
Retinal redetachment rate
Secondary Outcome Measure Information:
Title
visual acuity
Title
intraocular pressure
Title
reoperation
Title
relative afferent pupillary defect
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal
Exclusion Criteria:
any sign of retinal redetachment before silicone oil removal
any sign of diabetic retinopathy
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
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
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