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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00371020
• Collaborator: (none)
• Location: 1
• Duration (Months): 28.9

Study Details

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
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2005
• Anticipated Study Completion Date: Jul 1, 2007

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00371020
• Other Study ID Numbers: 8373
• First Posted: Sep 1, 2006
• Last Update Posted: Jul 12, 2007
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: silicone oil; PVR; retinal redetachment; low molecular weight heparin; 5-FU
• Additional relevant MeSH terms: Vitreoretinopathy, Proliferative; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin

Study Results

No Results Posted as of Jul 12, 2007