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Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
colchicine
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring retinal detachment, proliferative vitreoretinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Rhegmatogenous retinal detachment Exclusion Criteria: PVR grade C Duration of retinal detachment ≥ one month History of cataract surgery History of RD surgery

Sites / Locations

  • Hamid Ahmadieh,MD

Outcomes

Primary Outcome Measures

proliferative vitreoretinopathy
retinal reattachment rate

Secondary Outcome Measures

visual acuity
reoperation
macular pucker

Full Information

First Posted
August 30, 2006
Last Updated
October 6, 2006
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00370201
Brief Title
Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment
Keywords
retinal detachment, proliferative vitreoretinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
colchicine
Primary Outcome Measure Information:
Title
proliferative vitreoretinopathy
Title
retinal reattachment rate
Secondary Outcome Measure Information:
Title
visual acuity
Title
reoperation
Title
macular pucker

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rhegmatogenous retinal detachment Exclusion Criteria: PVR grade C Duration of retinal detachment ≥ one month History of cataract surgery History of RD surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh,MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

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