Actively Recruiting

Phase Not Applicable
All Genders
ID07146516

Ora Secunda Cerclage Laser Retinopexy to Prevent Retinal Detachment in Stickler Syndrome: A Prospective Historically Controlled Study

Led by Helen Keller Eye Research Foundation · Updated on 2026-05-26

500

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Helen Keller Eye Research Foundation

Lead Sponsor

F

Five Lakes Clinical Research Consulting, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying Stickler syndrome, a genetic condition that increases the risk of retinal detachment, to evaluate how well a laser treatment called Ora Secunda Cerclage laser retinopexy (OSC/SS) can prevent retinal detachment. This trial compares the effects of the OSC/SS procedure to the natural course of Stickler syndrome without treatment, using historical data from a large database. The study aims to provide standardized documentation and treatment parameters to better understand and potentially set a new standard for preventing retinal detachment in these patients. The OSC/SS procedure involves using indirect ophthalmoscopy to apply 1500 to 2500 moderate intensity laser burns arranged in a 360-degree encircling pattern around the retina. Participants will receive this prophylactic laser treatment in one or both eyes. The study enrolls children, adolescents, and adults with genetically confirmed Stickler syndrome types 1 or 2. This is an interventional study where all participants receive the laser treatment, which is carefully documented and standardized. Participants will attend nine visits over five years at the study center for eye exams, imaging, and tests including photographic fundus mapping, optical coherence tomography, intraocular pressure, pupil measurements, slit lamp biomicroscopy, motility assessments, and vision acuity testing. Genetic testing for Stickler syndrome may also be done if needed. Researchers will monitor the number of participants who develop retinal detachment after treatment, track adverse events, and assess visual outcomes. Data from the untreated eye will also be collected if available. The total participation time is five years post-procedure.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No contraindications to laser retinopexy surgery as determined by the local site
  • Capable of giving signed informed consent or assent as appropriate
  • Signed informed consent form from participant or legally authorized representative, parent, or guardian
  • Male or female of any age
  • Confirmation of Stickler syndrome type 1 or type 2 by genetic testing
Not Eligible

You will not qualify if you...

  • Presence of media opacity or poor pupil dilation that prevents adequate laser treatment or imaging
  • Prior prophylactic laser treatment that cannot be supplemented to complete the study laser pattern
  • Retinal detachment in the eye to be treated
  • Significant intraocular hemorrhage in the study eye
  • Uncontrolled eye conditions such as glaucoma that may worsen with the procedure
  • Any ocular condition preventing laser treatment under scleral depression
  • Any systemic medical condition where risks outweigh potential benefits
  • Known mutations in genes linked to other inherited retinal detachment syndromes
  • Other syndromes with increased retinal detachment risk such as Knobloch, Marfan, or Pierson syndrome
  • History of Coats disease
  • History of Retinopathy of Prematurity
  • Prior laser photocoagulation in the study eye except for specific indications related to Stickler syndrome
  • Previous cryopexy, scleral buckle, or vitrectomy in the study eye
  • Significant peripheral retinal disease unrelated to Stickler syndrome
  • History of ocular trauma causing significant posterior eye injury
  • Inability or unwillingness to comply with follow-up visits
  • Anticipated relocation or factors limiting long-term follow-up
  • Any other condition judged by investigators to affect trial safety or integrity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure with immediate recovery period

Participants undergo a prophylactic non-invasive laser retinopexy procedure to prevent retinal detachment using an encircling grid laser pattern.

1 procedure visit (in-person)

Follow-up

Duration - Up to 5 years after the procedure

Participants are monitored for safety and efficacy through recurring eye evaluations including photographic fundus mapping, intraocular pressure, vision testing, and other assessments.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 5 locations

1

Retina Specialists of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States, 48073

Actively Recruiting

3

Retina Consultants of Minnesota

Minneapolis, Minnesota, United States, 55435

Actively Recruiting

4

Long Island Vitreoretinal Consultants, PC

Westbury, New York, United States, 11590

Not Yet Recruiting

5

Tennessee Retina, P.C.

Nashville, Tennessee, United States, 37203

Actively Recruiting

Loading map...

Research Team

P

Peter J Belin, MD

F

Five Lakes Clinical Research Consultants, LLC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Similar Trials

Coordination of Rare Diseases at Sanford Patient Registry an...

Rare Disorders

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Retinal Detachment Prophylaxis for Patients With Stickler Syndrome: A Survey of Pediatric Retinal Specialist Treatment Preferences.

Ameay V Naravane, Peter J Belin, Polly A Quiram

https://pubmed.ncbi.nlm.nih.gov/36780636

Stickler Syndrome (SS): Laser Prophylaxis for Retinal Detachment (Modified Ora Secunda Cerclage, OSC/SS).

Robert E Morris, Edward Scott Parma, Nathaniel H Robin...

https://pubmed.ncbi.nlm.nih.gov/33447008