- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07260097
Choroidal Venous Congestion Following Scleral Buckling - An Imaging Study (SB)
Study Overview
Status
Conditions
Detailed Description
Scleral Buckling (SB) surgery emplaces a silicone band along the circumference of the eye to create an external support for retinal breaks, hence treating the retinal detachment. The investigators hypothesize that the presence of an external silicone band from the SB surgery would result in an increase in resistance across the choroidal venous outflow channels. This would in turn be manifested by quantitative and qualitative changes in choroidal vessel structure and architecture. These initial changes will eventually stabilise and revert to baseline after a period of long-term remodelling and adaptation.
Through this imaging study, the investigators aim to opportunistically study and validate these progressive choroidal vasculature changes in the choroidal outflow circulation following scleral buckle (SB) surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gemmy Cheung
- Phone Number: +6563227460
- Email: gemmy.cheung.c.m@singhealth.com.sg
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Singapore Eye Research Institute
-
Contact:
- Gemmy Cheung
- Phone Number: +6563227460
- Email: gemmy.cheung.c.m@singhealth.com.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 21 years and above
- Ability to provide informed consent
- First occurrence of a retinal detachment in one eye, deemed to require SB surgery with or without vitrectomy and/or cataract surgery.
- Clinically normal fellow eye (no previous intraocular surgery except for cataract extraction with lens implant, intraocular laser or injection procedures).
Exclusion Criteria:
- Affected eye undergoing vitreoretinal procedure other than an SB surgery with or without vitrectomy and/or cataract surgery.
- Pregnant or nursing women
- Persons who are unable to give informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative choroidal venous congestion
Time Frame: 1 year
|
Proportion of eyes demonstrating progression in choroidal venous congestion at 1 year, defined by increased choroidal thickness, increase in number of quadrants with pachyvessels, or new vortex vein anastomosis on multimodal imaging.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-0251
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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