Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Ora Secunda Cerclage Laser Retinopexy To Prevent Retinal Detachment In Stickler Syndrome (OSC/SS): A Prospective Historically Controlled Study
Helen Keller Eye Research Foundation
500 participants
Oct 30, 2025
INTERVENTIONAL
Conditions
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. 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
Eligibility
Inclusion Criteria5
- No contraindications to laser retinopexy surgery per local site criteria.
- 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 Criteria21
- 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.
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Interventions
Prophylactic laser retinopexy to prevent RD in participants with SS using the indirect ophthalmoscopy (IDO) to place approximately 1500 to 2500 moderate intensity burns to produce encircling grid pattern, placed one burn width apart from 2 MM anterior to the ora serrata, extending to and between the vortex vein ampullae.
Locations(2)
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NCT07146516