- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255293
Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Jason Hsu, MD, Mid Atlantic Retina
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAR-3
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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