Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
Primary Purpose
Retinal Detachment, Vitrectomy, Proliferative Vitreoretinopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1000 centistoke silicone oil
5000 centistoke silicone oil
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring Retinal detachment, Proliferative vitreoretinopathy, Diabetic retinopathy, Vitrectomy, Silicone oil
Eligibility 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.
Sites / Locations
- Wills Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1000 centistoke silicone oil
5000 centistoke silicone oil
Arm Description
Outcomes
Primary Outcome Measures
Retinal redetachment rate
Secondary Outcome Measures
Best-corrected visual acuity
Silicone oil emulsification rate
Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01255293
Brief Title
Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mid Atlantic Retina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Vitrectomy, Proliferative Vitreoretinopathy, Diabetic Retinopathy
Keywords
Retinal detachment, Proliferative vitreoretinopathy, Diabetic retinopathy, Vitrectomy, Silicone oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1000 centistoke silicone oil
Arm Type
Active Comparator
Arm Title
5000 centistoke silicone oil
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
1000 centistoke silicone oil
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
5000 centistoke silicone oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Retinal redetachment rate
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity
Time Frame
6 and 12 months
Title
Silicone oil emulsification rate
Description
Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.
Time Frame
Monthly
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32408387
Citation
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Results Reference
derived
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Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
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