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

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

Study Overview

Status

Completed

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

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
Single-operation retinal reattachment rate six
months after surgery.

Secondary Outcome Measures

Outcome Measure
Visual acuity
Intraocular pressure
Retinal reproliferation
Early silicone oil emulsification

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

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.

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