Laser eye surgery could prevent blindness in rare genetic condition
NCT ID NCT07146516
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a laser treatment called OSC/SS to prevent retinal detachment in people with Stickler Syndrome, a genetic condition that raises the risk of vision loss. About 500 children and adults will receive the procedure in one or both eyes and be followed for 5 years. Researchers will compare their outcomes to the natural course of the disease to see if the laser helps keep the retina attached.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Associated Retinal Consultants, P.C.
RECRUITINGRoyal Oak, Michigan, 48073, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Retina Consultants of Minnesota
RECRUITINGMinneapolis, Minnesota, 55435, United States
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Retina Specialists of Alabama
RECRUITINGBirmingham, Alabama, 35233, United States
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Tennessee Retina, P.C.
RECRUITINGNashville, Tennessee, 37203, United States
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