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 range5 Years – 35 Years
SexALL
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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…
What they're measuring
1
Best corrected visual acuity and retinal detachment rate