- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00371020
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
July 11, 2007 updated by: Shahid Beheshti University of Medical Sciences
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of, 16666
- Hamid Ahmadieh, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Retinal redetachment rate
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Secondary Outcome Measures
Outcome Measure |
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visual acuity
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intraocular pressure
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reoperation
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relative afferent pupillary defect
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Study Completion (Anticipated)
July 1, 2007
Study Registration Dates
First Submitted
August 31, 2006
First Submitted That Met QC Criteria
August 31, 2006
First Posted (Estimate)
September 1, 2006
Study Record Updates
Last Update Posted (Estimate)
July 12, 2007
Last Update Submitted That Met QC Criteria
July 11, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8373
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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