Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome (NCT04465188) | Clinical Trial Compass
WithdrawnPhase 2
Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome
Stopped: No inclusion
France0Started 2023-06
Plain-language summary
The purpose of this study is to determine whether a scleral buckling surgical procedure performed on fellow eyes of patients with genetically confirmed Stickler syndrome can prevent the occurrence retinal detachment and/or severe vision loss of the study eye.
Who can participate
Age range
5 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Genetically confirmed Stickler Syndrome
* Aged 5 to 35
* Recent retinal detachment in the non-study eye (\<24 months)
* Signed informed consent to participate in the study; For the minors, information and consent of the holders of parental authority
* Sufficient patient cooperation to perform a complete ophthalmologic examination including a dilated fundus examination
* Patients affiliated with social security or CMU (profit or being entitled)
Exclusion Criteria:
* • Any type of previous prevention (laser, cryotherapy, scleral buckle) for the study eye
* Subclinical retinal rhegmatogenous detachment in the study eye.
* Any other ocular disease unrelated to Stickler syndrome significantly affecting visual acuity (ETDRS BCVA\<20/400).
* Contraindications to general anesthesia
* Posterior vitreoretinal traction on optical coherence tomography
* Pregnant or breastfeeding women
* Any patient presenting an intraocular pressure during the inclusion visit (M-3) greater than 30 mm Hg
* Hypersensitivity to povidone iodine, iodine or any of the excipients of the specialty used
* Hypersensitivity to acetazolamide or any of the excipients of the specialty used
* Severe hepatic, renal or adrenal insufficiency
* Sulfonamide intolerance
* History of renal colic
* Pre-existing plasma hyperosmolarity
* Predominantly intracellular dehydration
* Hypersensitivity to dexamethasone or any of the excipients of the specialty used
* Hypersensitivity to oxytetracycline or to an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best corrected visual acuity and retinal detachment rate