Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
United States500 participantsStarted 2025-10-30
Plain-language 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
Who can participate
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
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
Timeframe: From enrollment to post initial procedure at 5 years
. 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).