NCT07146516

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Helen Keller Eye Research Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

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 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 for Stickler syndrome based on retrospective evidence. A statistical review of pertinent articles concluded that prophylactic laser therapy was associated with a significantly lower risk of retinal detachment in patients with Stickler syndrome compared to no laser prophylaxis. This clinical trial is designed to offer OSC/SS as the optimal form of such prevention, and to prospectively document, in a standardized manner, the extent to which it prevents retinal detachment in patients with Stickler syndrome. This clinical trial aims to address the lack of standardized documentation in previous literature and studies by providing standardized treatment parameters and rigorously documenting the OSC/SS technique. By evaluating the safety and efficacy of OSC/SS in preventing RD in Stickler syndrome patients, this study seeks to establish a benchmark for future clinical practice and research. The primary objective is to demonstrate the efficacy of the OSC/SS procedure compared to the natural progression of SS to prevent RD for individuals with SS. This comparison will be made using historical control data provided by Cambridge University, which documents the rate of occurrence of RD in the absence of prior prophylactic treatment. Cambridge University maintains a large SS database, consisting of decades of clinical and research data on Stickler syndrome populations, providing the necessary control raw data for this study population. If the OSC/SS procedure proves to be adequately successful in the study, then it may become the gold standard treatment used to prevent RD in patients with SS and, with modifications, other populations at high risk for RD. Enrollment is competitive.

Conditions

• Stickler Syndrome Type 1
• Stickler Syndrome Type 2

Interventions

Type	Name	Description
PROCEDURE	Prophylactic (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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2035-12-01
• Completion: 2035-12-01
• First posted: 2025-08-28
• Last updated: 2026-04-09

Locations

2 sites across 1 country: United States