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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255293
First Posted: December 7, 2010
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mid Atlantic Retina
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jason Hsu, Mid Atlantic Retina
ClinicalTrials.gov Identifier: NCT01255293     History of Changes
Other Study ID Numbers: MAR-3
First Submitted: December 6, 2010
First Posted: December 7, 2010
Last Update Posted: June 14, 2013
Last Verified: June 2013

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

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