Status:
WITHDRAWN
Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsena...
Detailed Description
This surgery can be performed alone or at the same time as cataract surgery. The geometry of the Xen® implant has been studied to help prevent major hypotonia. This new technique would also prevent co...
Eligibility Criteria
Inclusion
- Man or woman aged ≥ 18 years
- French-speaking patient
- Patients followed for primary or secondary open-angle glaucoma in the ophthalmology department of the GhPSJ
- Patient with an indication for surgery with placement of Xen® or NDPS alone or combined with cataract surgery by phacoemulsification of the lens
- Patient affiliated to social security or, failing that, to another health insurance system
- Patient capable of giving free, informed and express consent.
Exclusion
- Patient with another associated ophthalmological disease, apart from a simple cataract already operated on or operated simultaneously with NDPS or the Xen® break without complications during or after the operation
- History of filtering surgery, history of vitrectomy
- Closed-angle glaucoma
- Pseudo capsular exfoliation (connective tissue disease affecting the eye)
- Uveitic glaucoma (glaucoma related to inflammation which can itself have an effect on the cornea)
- Prolonged postoperative hypertonia (7 days)\> 40 mmHG (because this can damage the cells of the cornea)
- Pre-existing endothelial dystrophy, irido-corneo-endothelial syndrome (ICE) (glaucoma with corneal pathology)
- Postoperative athalamy (contact between the iris and the cornea generating endothelial cell loss)
- Endothelial cell count \<1000 cells
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04781283
Start Date
November 15 2021
End Date
November 15 2021
Last Update
February 1 2022
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