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

This study has been completed.
Sponsor:
Information provided by:
Mid Atlantic Retina
ClinicalTrials.gov Identifier:
NCT01255293
First received: December 6, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Retinal Detachment
Vitrectomy
Proliferative Vitreoretinopathy
Diabetic Retinopathy
Procedure: 1000 centistoke silicone oil
Procedure: 5000 centistoke silicone oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mid Atlantic Retina:

Primary Outcome Measures:
  • Retinal redetachment rate [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Silicone oil emulsification rate [ Time Frame: Monthly ] [ Designated as safety issue: No ]
    Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.


Enrollment: 15
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1000 centistoke silicone oil Procedure: 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 Procedure: 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255293

Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Mid Atlantic Retina
Investigators
Principal Investigator: Jason Hsu, MD Mid Atlantic Retina
  More Information

No publications provided

Responsible Party: Jason Hsu, Mid Atlantic Retina
ClinicalTrials.gov Identifier: NCT01255293     History of Changes
Other Study ID Numbers: MAR-3
Study First Received: December 6, 2010
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mid Atlantic Retina:
Retinal detachment
Proliferative vitreoretinopathy
Diabetic retinopathy
Vitrectomy
Silicone oil

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Detachment
Retinal Diseases
Vitreoretinopathy, Proliferative
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014