Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments

June 13, 2013 updated by: Mid Atlantic Retina

A Prospective, Randomized Study Comparing 1000 Centistoke and 5000 Centistoke Silicone Oil Tamponade for Repair of Proliferative Vitreoretinopathy Retinal Detachments and Diabetic Tractional Retinal Detachments

The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.

Study Overview

Detailed Description

As part of retinal detachment surgery, the eye is typically filled with a gas bubble or silicone oil bubble. This bubble acts like a balloon inside the eye and helps to keep the retina pushed back against the eye wall so it can heal in its proper place. Gas bubbles spontaneously dissolve over a few weeks whereas silicone oil remains in the eye until removed with another surgery. When retinal detachments are associated with significant scar tissue on the retinal surface, silicone oil is often used since it can remain filling the eyeball for as long as necessary to help the retina to heal properly in place. Currently, two different types of silicone oil (1000 centistoke and 5000 centistoke) are commercially available and have been approved for use in the eye by the Food and Drug Administration. The goal of the study is to compare the outcomes using these two different types of silicone oil.

The retinal detachment will be repaired in a standard fashion. There will be no difference between the way retinal detachments are repaired in this study compared to those not in this study. Patients will be randomly assigned (like a flip of a coin) to receive one of the types of silicone oil. Both types of oil have very similar characteristics. The primary difference is that one type is thicker (more viscous) than the other, analogous to honey in comparison with maple syrup.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade C or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy.
  • Judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment.
  • Visual acuity of light perception or better.
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

  • Inability to re-attach the retina at the time of surgery.
  • Prior trabeculectomy or tube shunt surgery.
  • Corneal opacity which limits visualization of the trabecular meshwork.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1000 centistoke silicone oil
Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 1000 centistoke silicone oil.
Active Comparator: 5000 centistoke silicone oil
Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 5000 centistoke silicone oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal redetachment rate
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
Time Frame: 6 and 12 months
6 and 12 months
Silicone oil emulsification rate
Time Frame: Monthly
Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.
Monthly

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jason Hsu, MD, Mid Atlantic Retina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

November 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

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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