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

Recruiting now · Not applicable

Conditions studied: Stickler Syndrome Type 1, Stickler Syndrome Type 2

In brief

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

Key facts

Study ID

NCT07146516

Run by

Helen Keller Eye Research Foundation

People needed

500

Starts

2025-10-30

Expected to finish

2035-12-01

Last updated by the study team

2026-07-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser treatment, or imaging.
• Prior prophylactic laser treatment that cannot be supplemented to achieve a complete OSC/SS pattern or exceeds the designated OSC/SS pattern.
• RD in the eye to be treated.
• Significant intraocular hemorrhage in the eye to be treated.
• Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up.
• Any other ocular condition that precludes the ability to perform adequate laser treatment under scleral depression.
• Any systemic medical contraindication where the risk of intervention outweighs the potential benefit.
• 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).
• Other syndromes associated with increased risk of retinal detachment (for example, Knobloch syndrome, Marfan syndrome, Pierson syndrome).
• History of Coats disease.
• History of Retinopathy of Prematurity (with or without laser treatment).
• 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.
• Laser photocoagulation, for the indications permitted in exclusion criteria 12, that cannot be supplemented to meet the OSC/SS criteria.
• Previous cryopexy.
• Previous scleral buckle.
• Previous vitrectomy in the study eye for any reason.
• 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.
• 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.
• Inability or unwillingness to comply with required follow-up schedule (clinical visits, imaging).
• Anticipated relocation, foster care instability, or any factor significantly limiting longitudinal follow-up.
• Investigator judgment: Any condition not listed above that could interfere with the trial's integrity or subject safety.

Where it is running

• Retina Specialists of Alabama — Birmingham, Alabama, United States (enrolling)
• Associated Retinal Consultants, P.C. — Royal Oak, Michigan, United States (enrolling)
• Retina Consultants of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Tennessee Retina, P.C. — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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