Ora Secunda Cerclage Laser Retinopexy To Prevent Retinal Detachment In Stickler Syndrome (OSC/SS): A Prospective Historically Controlled Study
Helen Keller Eye Research Foundation
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
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 for Stickler syndrome. There is significant, but only retrospective, evidence in the scientific literature that non-invasive, encircling (360 degree) laser prophylaxis (cerclage prophylaxis) reduces the rate of retinal detachment in patients with Stickler syndrome by approximately five-fold. In February 2025, the American Academy of Ophthalmology (AAO) endorsed 360-degree cerclage laser prophylaxis…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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. Pr…
Interventions
- ProcedureProphylactic (non-invasive) Laser Retinopexy
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 (4)
- Retina Specialists of AlabamaBirmingham, Alabama
- Associated Retinal Consultants, P.C.Royal Oak, Michigan
- Retina Consultants of MinnesotaMinneapolis, Minnesota
- Long Island Vitreoretinal Consultants, PCWestbury, New York