Status:
NOT_YET_RECRUITING
Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Stickler Syndrome
Eligibility:
All Genders
5-35 years
Phase:
PHASE2
Brief 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 ret...
Detailed Description
Stickler syndrome (STL) is a genetic disease affecting several organs. However the major risk is represented by the development of retinal detachment (RD). Up to 80% of patients present a RD and 25% t...
Eligibility Criteria
Inclusion
- 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
- Sufficient patient cooperation to perform a complete ophthalmologic examination including a dilated fundus examination
Exclusion
- 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
- Intraoperative detection of one or more of the above-mentioned non-inclusion criteria
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04465188
Start Date
June 1 2023
End Date
January 1 2030
Last Update
February 8 2023
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014