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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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ClinicalTrials.gov Identifier: NCT00371020
Recruitment Status : Unknown
Verified July 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : July 12, 2007
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Proliferative Vitreoretinopathy Drug: low molecular weight heparin, 5-FU Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2005
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Retinal redetachment rate

Secondary Outcome Measures :
  1. visual acuity
  2. intraocular pressure
  3. reoperation
  4. relative afferent pupillary defect

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371020


Locations
Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
More Information

ClinicalTrials.gov Identifier: NCT00371020     History of Changes
Other Study ID Numbers: 8373
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: July 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
silicone oil
PVR
retinal redetachment
low molecular weight heparin
5-FU

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action