Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
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|ClinicalTrials.gov Identifier: NCT01255293|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Retinal Detachment Vitrectomy Proliferative Vitreoretinopathy Diabetic Retinopathy||Procedure: 1000 centistoke silicone oil Procedure: 5000 centistoke silicone oil||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|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
- Retinal redetachment rate [ Time Frame: Six months ]
- 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.
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
|United States, Pennsylvania|
|Wills Eye Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jason Hsu, MD||Mid Atlantic Retina|