Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was  Active, not recruiting
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: August 31, 2006
Last updated: July 11, 2007
Last verified: July 2007
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 Intervention Phase
Proliferative Vitreoretinopathy
Drug: low molecular weight heparin, 5-FU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Retinal redetachment rate

Secondary Outcome Measures:
  • visual acuity
  • intraocular pressure
  • reoperation
  • relative afferent pupillary defect

Study Start Date: February 2005
Estimated Study Completion Date: July 2007

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00371020

Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information Identifier: NCT00371020     History of Changes
Other Study ID Numbers: 8373 
Study First Received: August 31, 2006
Last Updated: July 11, 2007
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016