Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy

This study has been completed.

First Received on September 7, 2006. Last Updated on October 11, 2006 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00373282

Purpose

To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.

Condition	Intervention	Phase
Proliferative Vitreoretinopathy	Drug: Triamcinolone acetonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Silicone

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Single-operation retinal reattachment rate six
months after surgery.

Secondary Outcome Measures:

Visual acuity
Retinal reproliferation
Intraocular pressure
Early silicone oil emulsification

Study Start Date:	June 2001
Estimated Study Completion Date:	June 2003

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373282

Locations

Iran, Islamic Republic of
Hamid Ahmadieh,MD
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed 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:	NCT00373282 History of Changes
Other Study ID Numbers:	8116
Study First Received:	September 7, 2006
Last Updated:	October 11, 2006
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

PVR
Retinal detachment
Silicone oil
Triamcinolone

Additional relevant MeSH terms:

Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012