360-degree laser cerclage (OSC/SS) to prevent retinal detachment in Stickler syndrome.

Ora Secunda Cerclage Laser Retinopexy To Prevent Retinal Detachment In Stickler Syndrome (OSC/SS): A Prospective Historically Controlled Study

The OSC/SS 360-degree laser procedure will be tried to see if it prevents retinal detachment in children and adults with Stickler syndrome types 1 or 2.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sex: All
• Sponsor: Helen Keller Eye Research Foundation (Academic / other)
• Locations: 4 sites (Birmingham, Alabama and 3 other locations)
• Trial ID: NCT07146516 on ClinicalTrials.gov

What this trial studies

This prospective study will offer a standardized OSC/SS (Ora Secunda Cerclage for Stickler syndrome) 360-degree prophylactic laser retinopexy to one or both eyes and document outcomes over five years. Treated eyes will receive the OSC/SS protocol while available untreated fellow eyes and natural history data will be used for comparison. Participants will have genetic confirmation of Stickler syndrome as needed, baseline and follow-up eye tests, and up to nine clinic visits over five years for imaging and safety checks. The protocol aims to standardize treatment parameters and rigorously record safety and retinal detachment rates.

Who should consider this trial

Good fit: Ideal candidates are people of any age with genetically confirmed Stickler syndrome type 1 or 2 who can give consent (or have a guardian/parent consent), have no contraindications to laser retinopexy, and do not have a retinal detachment in the eye planned for treatment.

Not a fit: Patients who already have a retinal detachment in the eye to be treated, have media opacities or poor pupil dilation that prevent adequate laser treatment, have uncontrolled ocular disease, or whose prior laser treatment cannot be completed to the OSC/SS pattern may not benefit from this procedure.

Why it matters

Potential benefit: If successful, the OSC/SS procedure could substantially reduce the risk of retinal detachment and help preserve vision in people with Stickler syndrome.

How similar studies have performed: Retrospective studies report about a five-fold lower rate of retinal detachment with 360° cerclage laser in Stickler syndrome and the American Academy of Ophthalmology has recently endorsed the approach, but prospective standardized data remain limited.

Eligibility criteria

Inclusion Criteria:

1. No contraindications to laser retinopexy surgery per local site criteria.
2. Capable of giving signed informed consent, and assent (as appropriate)
3. Signature of research informed consent form from participant, or participant's legally authorized representative (LAR)/parent(s)/legal guardian
4. Male or female of any age
5. SS type 1 or type 2 confirmed by genetic testing

Exclusion Criteria:

1. Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser treatment, or imaging.
2. Prior prophylactic laser treatment that cannot be supplemented to achieve a complete OSC/SS pattern or exceeds the designated OSC/SS pattern.
3. RD in the eye to be treated.
4. Significant intraocular hemorrhage in the eye to be treated.
5. Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up.
6. Any other ocular condition that precludes the ability to perform adequate laser treatment under scleral depression.
7. Any systemic medical contraindication where the risk of intervention outweighs the potential benefit.
8. 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).
9. Other syndromes associated with increased risk of retinal detachment (for example, Knobloch syndrome, Marfan syndrome, Pierson syndrome).
10. History of Coats disease.
11. History of Retinopathy of Prematurity (with or without laser treatment).
12. Previous laser photocoagulation in the study eye for any indication, including Retinopathy of prematurity (ROP) Panretinal photocoagulation for diabetic retinopathy.
13. Laser to lattice degeneration or 360-degree laser cerclage for Stickler Syndrome that cannot be supplemented to meet OSC/SS criteria.
14. Previous cryopexy.
15. Previous scleral buckle.
16. Previous vitrectomy in the study eye for any reason.
17. 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.
18. 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.
19. Inability or unwillingness to comply with required follow-up schedule (clinical visits, imaging).
20. Anticipated relocation, foster care instability, or any factor significantly limiting longitudinal follow-up.
21. Investigator judgment: Any condition not listed above that could interfere with the trial's integrity or subject safety.

Where this trial is running

Birmingham, Alabama and 3 other locations

• Retina Specialists of Alabama — Birmingham, Alabama, United States (Recruiting)
• Associated Retinal Consultants, P.C. — Royal Oak, Michigan, United States (Recruiting)
• Retina Consultants of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• Long Island Vitreoretinal Consultants, PC — Westbury, New York, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Peter J Belin, MD — Retina Consultants of Minnesota
• Study coordinator: Peter J Belin, MD

Conditions Stickler Syndrome Type 1; Stickler Syndrome Type 2; prophylactic laser retinopexy; Ora Secunda Cerclage; laser; prophylactic; retinopexy; Stickler syndrome