Actively Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Led by Helen Keller Eye Research Foundation · Updated on 2026-05-08
500
Participants Needed
4
Research Sites
526 weeks
Total Duration
On this page
Sponsors
H
Helen Keller Eye Research Foundation
Lead Sponsor
F
Five Lakes Clinical Research Consulting, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to prospectively document to what extent the OSC/SS prophylactic laser retinopexy procedure works to prevent retinal detachment in SS in children and adults. Researchers will compare the OSC/SS procedure in SS to the natural progression of SS to see to what extent the OSC/SS procedure works to prevent retinal detachment. Participants will: * Have the OSC/SS procedure in one or both eyes * Have eye tests * Have genetic testing for SS as needed * Visit the study center 9 times over 5 years for checkups and tests * Have data for the untreated fellow-eye collected and used as study data if available
CONDITIONS
Official Title
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No contraindications to laser retinopexy surgery per local site criteria
- Able to provide signed informed consent or assent as appropriate
- Male or female of any age
- Stickler syndrome type 1 or type 2 confirmed by genetic testing
- Signature of research informed consent from participant or legally authorized representative/parent/legal guardian
You will not qualify if you...
- Presence of media opacity (such as dense cataract or corneal scar) or poor pupil dilation that prevents adequate laser treatment or imaging
- Prior prophylactic laser treatment that cannot be supplemented to achieve complete OSC/SS pattern or exceeds designated pattern
- Retinal detachment in the eye to be treated
- Significant intraocular hemorrhage in the eye to be treated
- Uncontrolled ocular conditions (e.g., glaucoma) that may worsen with the procedure or prevent follow-up
- Any other ocular condition preventing adequate laser treatment under scleral depression
- Systemic medical contraindications where risks outweigh potential benefits
- Known pathogenic mutations in genes linked to other inherited retinal detachment syndromes (e.g., FEVR-related genes, NDPX-linked retinoschisis, Wagner Syndrome)
- Other syndromes increasing retinal detachment risk (e.g., Knobloch, Marfan, Pierson syndromes)
- History of Coats disease
- History of Retinopathy of Prematurity with or without laser treatment
- Previous laser photocoagulation in the study eye for any indication
- Previous cryopexy, scleral buckle, or vitrectomy in the study eye
- Significant peripheral retinal pathology unrelated to Stickler syndrome increasing detachment risk
- History of ocular trauma with significant posterior segment injury
- Inability or unwillingness to comply with required follow-up visits and imaging
- Anticipated relocation, foster care instability, or other factors limiting long-term follow-up
- Any condition judged by investigator to interfere with trial integrity or subject safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Retina Specialists of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
3
Retina Consultants of Minnesota
Minneapolis, Minnesota, United States, 55435
Actively Recruiting
4
Long Island Vitreoretinal Consultants, PC
Westbury, New York, United States, 11590
Not Yet Recruiting
Research Team
P
Peter J Belin, MD
CONTACT
F
Five Lakes Clinical Research Consultants, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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