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Prevention study for Stickler Syndrome Type 1
Official title Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
ClinicalTrials.gov ID: NCT07146516
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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 likely can't join if
- Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser...
- 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.
See the full eligibility 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Royal Oak, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.