Status:
RECRUITING
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Lead Sponsor:
Helen Keller Eye Research Foundation
Collaborating Sponsors:
Five Lakes Clinical Research Consulting, LLC
Conditions:
Stickler Syndrome Type 1
Stickler Syndrome Type 2
Eligibility:
All Genders
Phase:
NA
Brief Summary
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. Resear...
Detailed Description
Prophylactic treatment for RD has been well-documented to be safe and effective for specific predisposing conditions, but parameters are not standardized and are poorly documented in the literature fo...
Eligibility Criteria
Inclusion
- Eligible for prophylactic laser retinopexy
- Capable of giving signed informed consent, and assent (as appropriate)
- Signature of research informed consent form from participant, or participant's legally authorized representative (LAR)/parent(s)/legal guardian
- Male or female of any age
- SS type 1 or type 2 confirmed by genetic testing
Exclusion
- Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser treatment, or imaging.
- Prior prophylactic laser treatment that cannot be supplemented to achieve a complete OSC/SS pattern or exceeds the designated OSC/SS pattern.
- RD in the eye to be treated.
- Significant intraocular hemorrhage in the eye to be treated.
- Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up.
- Any other ocular condition that precludes the ability to perform adequate laser treatment under scleral depression.
- Any systemic medical contraindication where the risk of intervention outweighs the potential benefit.
- Known pathogenic mutations in genes associated with other inherited retinal detachment syndromes, including but not limited to: FEVR-related genes: FZD4, LRP5, TSPAN12, NDPX-linked retinoschisis (RS1) Wagner Syndrome (VCAN).
- Other syndromes associated with increased risk of retinal detachment (for example, Knobloch syndrome, Marfan syndrome, Pierson syndrome).
- History of Coats disease.
- History of Retinopathy of Prematurity (with or without laser treatment).
- Previous laser photocoagulation in the study eye for any indication, including Retinopathy of prematurity (ROP) Panretinal photocoagulation for diabetic retinopathy.
- Laser to lattice degeneration or 360-degree laser cerclage for Stickler Syndrome that cannot be supplemented to meet OSC/SS criteria.
- Previous cryopexy.
- Previous scleral buckle.
- Previous vitrectomy in the study eye for any reason.
- Significant peripheral retinal pathology unrelated to Stickler that increases the risk of retinal detachment including but not limited to: retinoschisis, hemorrhages, angiomatous lesions, pars planitis.
- History of ocular trauma with significant trauma to the posterior segment of the eye and may increase the risk of retinal detachment including Ruptured globe, Vitreous hemorrhage, Commotio retinae, Traumatic macular hole, Intraocular foreign body.
- Inability or unwillingness to comply with required follow-up schedule (clinical visits, imaging).
- Anticipated relocation, foster care instability, or any factor significantly limiting longitudinal follow-up.
- Investigator judgment: Any condition not listed above that could interfere with the trial's integrity or subject safety.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07146516
Start Date
October 30 2025
End Date
December 1 2035
Last Update
January 9 2026
Active Locations (2)
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1
Retina Specialists of Alabama
Birmingham, Alabama, United States, 35233
2
Retina Consultants of Minnesota
Minneapolis, Minnesota, United States, 55435