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NCT00371020 Clinical Trial

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

Proliferative Vitreoretinopathy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00371020
Other study ID # 8373
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received August 31, 2006
Last updated July 11, 2007
Start date February 2005
Est. completion date July 2007

Study information
Verified date July 2007
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• low molecular weight heparin, 5-FU

Locations
Country Name City State
Iran, Islamic Republic of Hamid Ahmadieh, MD Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retinal redetachment rate
Secondary visual acuity
Secondary intraocular pressure
Secondary reoperation
Secondary relative afferent pupillary defect
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