Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial

June 25, 2008 updated by: Shahid Beheshti University of Medical Sciences
To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment

Study Overview

Status

Unknown

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 Contact

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B

Exclusion Criteria:

  • PVR grade C
  • History of surgery for RD
  • Signs of diabetic retinopathy, AMD, glaucoma and macular hole
  • History of ocular trauma
  • 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
scleral buckling
Procedure: scleral buckling, primary vitrectomy
Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 2
Primary vitrectomy without encircling band
Procedure: scleral buckling, primary vitrectomy
Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 3
Primary vitrectomy with encircling band
Procedure: scleral buckling, primary vitrectomy
Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 4
Triamcinolone assisted vitrectomy
Procedure: scleral buckling, primary vitrectomy
Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual acuity
Retinal reattachment rate

Secondary Outcome Measures

Outcome Measure
Proliferative vitreoretinopathy
Macular Pucker
Anisometropia
Choroidal detachment
Reoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

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

September 1, 2005

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2008

Last Update Submitted That Met QC Criteria

June 25, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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