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 Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371020
First received: August 31, 2006
Last updated: July 11, 2007
Last verified: July 2007
  Purpose

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 Medical University:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371020

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

No publications provided

ClinicalTrials.gov 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 Medical University:
silicone oil
PVR
retinal redetachment
low molecular weight heparin
5-FU

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Fluorouracil
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 14, 2014