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

This study has been completed.

First Received: September 7, 2006 Last Updated: 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:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Surgery

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

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

Keywords provided by Shaheed Beheshti Medical University:

PVR
Retinal detachment
Silicone oil
Triamcinolone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Triamcinolone diacetate
Immunosuppressive Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Triamcinolone hexacetonide
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Vitreoretinopathy, Proliferative
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010