Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
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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 |
- Retinal redetachment rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
- 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.
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 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 |
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| Contact: Michele Formoso | 215-928-3092 | research@midatlanticretina.com |
| United States, Pennsylvania | |
| Wills Eye Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Michele Formoso 215-928-3092 research@midatlanticretina.com | |
| Principal Investigator: Jason Hsu, MD | |
| Sub-Investigator: Sunir J Garg, MD | |
| Sub-Investigator: Allen C Ho, MD | |
| Sub-Investigator: Richard S Kaiser, MD | |
| Sub-Investigator: Joseph I Maguire, MD | |
| Sub-Investigator: Carl H Park, MD | |
| Sub-Investigator: Carl D Regillo, MD | |
| Sub-Investigator: Arunan Sivalingam, MD | |
| Sub-Investigator: Marc J Spirn, MD | |
| 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: | February 8, 2012 |
| 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 May 23, 2013