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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 14, 2013
June 1, 2013
1.9 years
December 6, 2010
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retinal redetachment rate
Six months
Secondary Outcomes (2)
Best-corrected visual acuity
6 and 12 months
Silicone oil emulsification rate
Monthly
Study Arms (2)
1000 centistoke silicone oil
ACTIVE COMPARATOR5000 centistoke silicone oil
ACTIVE COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
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.
PMID: 32408387DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Hsu, MD
Mid Atlantic Retina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 7, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 14, 2013
Record last verified: 2013-06