Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS) (OSC/SS)

May 22, 2026 updated by: Helen Keller Eye Research Foundation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Retina Specialists of Alabama
        • Contact:
        • Principal Investigator:
          • Mathew Sapp, MD
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Associated Retinal Consultants, P.C.
        • Contact:
        • Principal Investigator:
          • Matthew Trese, D.O.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Recruiting
        • Retina Consultants of Minnesota
        • Contact:
        • Principal Investigator:
          • Peter J Belin, MD
    • New York
      • Westbury, New York, United States, 11590
        • Not yet recruiting
        • Long Island Vitreoretinal Consultants, PC
        • Principal Investigator:
          • Philip Ferrone, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina, P.C.
        • Contact:
        • Principal Investigator:
          • Franco Recchia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. Prior laser photocoagulation in the study eye for any indication other than the following: retinal detachment prophylaxis for Stickler syndrome, treatment of lattice degeneration, or treatment of retinal tears.
  13. Laser photocoagulation, for the indications permitted in exclusion criteria 12, that cannot be supplemented to meet the 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy
Intervention: Children, Adolescents, and Adults with SS treated with prophylactic laser retinopexy procedure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with SS who Develop RD After Undergoing the OSC/SS Procedure as Assessed by One of the Following Photographic Fundus Mapping and IDO Examinations
Time Frame: From enrollment to post initial procedure at 5 years
Efficacy of the OSC/SS procedure in preventing RD in participants with type 1 (STL1) and type 2 (STL2) SS will be assessed annually by tracking the number of participants who develop RD after undergoing the OSC/SS procedure, using data from one of the following: photographic fundus mapping and IDO examinations.
From enrollment to post initial procedure at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of Retinal Defects
Time Frame: From enrollment to post initial procedure at 5 years
Annually assess the size (measured in clock hours) of retinal defects including giant retinal tears (GRT) in participants experiencing retinal defects after undergoing the OSC/SS procedure, using IDO examinations compared to the natural course of SS.
From enrollment to post initial procedure at 5 years
Number of Occurrences of Retinal Defects
Time Frame: From enrollment to post initial procedure at 5 years
Annually assess by tracking the number of occurrences of participants experiencing retinal defects including giant retinal tears after undergoing the OSC/SS procedure, using the number of unique retinal defect forms received for each participant.
From enrollment to post initial procedure at 5 years
Number of Participants Experiencing Retinal Defects
Time Frame: From enrollment to post initial procedure at 5 years
Annually assess by tracking the number of participants experiencing retinal defects after undergoing the OSC/SS procedure, using data from one of the following: photographic fundus mapping and IDO examinations.
From enrollment to post initial procedure at 5 years
Number of Surgeries to Repair Retinal Detachments or Retinal Defects
Time Frame: From enrollment to post initial procedure at 5 years
Annually assess by tracking the number of surgeries to repair retinal detachments or retinal defects in participants after undergoing the OSC/SS procedure, using the number of surgeries documented on the retinal defect forms received for each participant.
From enrollment to post initial procedure at 5 years
Measurement of Visual Acuity in Participants with SS Before and After the OSC/SS Procedure as Assessed by Using Standard of Care Methods
Time Frame: From enrollment to post initial procedure at 5 years
Impact of the OSC/SS procedure on visual acuity in participants with SS will be measured by standard of care methods including visual acuity charts and optical coherence tomography (OCT) imaging of the macula.
From enrollment to post initial procedure at 5 years
Number of Procedure Deviations by Treating Physicians as Assessed by Photographic Fundus Mapping
Time Frame: 3 to 6 months post OSC/SS procedure
Evaluate the compliance of treating physicians in correctly performing the OSC/SS procedure on participants with SS by tracking the number of procedure deviations including protocol specified grid coverage, burn spacing, and burn intensity by conducting a central review of photographic fundus mapping.
3 to 6 months post OSC/SS procedure
Frequency of Adverse Events as Assessed by Recurring Eye Evaluations (photographic fundus mapping, OCT, intraocular pressure, pupil measurements, slit lamp biomicroscopy, motility assessments, and vision acuity testing)
Time Frame: From enrollment to post initial procedure at 5 years
Annual evaluation of the safety of the OSC/SS procedure will be assessed by reviewing adverse events collected from recurring visual history and eye evaluations (photographic fundus mapping, OCT, intraocular pressure, pupil measurements, slit lamp biomicroscopy, motility assessments, and vision acuity testing).
From enrollment to post initial procedure at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helen Keller Eye Research Foundation

Collaborators

Five Lakes Clinical Research Consulting, LLC

Investigators

  • Study Director: Robert E Morris, MD, Helen Keller Eye Research Foundation
  • Principal Investigator: Peter J Belin, MD, Retina Consultants of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Actual)

August 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSC/SS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 9 months after publication of primary outcomes, ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

To achieve aims in the approved proposal.

Proposals should be directed to lbeckwith@helenkellerfoundation.org. If proposals are approved after review by regulatory counsel, requestors will need to enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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