- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373282
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
October 11, 2006 updated by: Shahid Beheshti University of Medical Sciences
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of, 16666
- Hamid Ahmadieh,MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.
Exclusion Criteria:
- History of trauma
- Presence of diabetic retinopathy
- History of vein occlusion
- Giant retinal tear
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Single-operation retinal reattachment rate six
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months after surgery.
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Secondary Outcome Measures
Outcome Measure |
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Visual acuity
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Intraocular pressure
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Retinal reproliferation
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Early silicone oil emulsification
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
October 12, 2006
Last Update Submitted That Met QC Criteria
October 11, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Diseases
- Vitreoretinopathy, Proliferative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 8116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.