Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Glaucoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 complications related to conjunctival dissection, while being faster. The placement of a Xen® implant ...

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 complications related to conjunctival dissection, while being faster. The placement of a Xen® implant is now used in simple surgery or combined with cataract surgery for open-angle glaucomas, beginners to moderate, associated or not with cataract, progressive and unbalanced under local hypotonizing treatment. Since June 2017, the Xen® technique has been part of the routine in the ophthalmology department of the Paris Saint-Joseph Hospital Group (GhPSJ). The choice of technique (filtering surgery or XEN®) is left to the discretion of the surgeon. To date, no study has yet compared the efficacy and safety of this new technique compared to non-perforating deep sclerectomy: the gold standard. However, the presence of any type of anterior chamber device may be associated with endothelial cell loss even when the device is not in direct contact with the cornea. Endothelial cell loss increases over time well after the operative procedure and sometimes requires removal of the device years later. It can induce non-reversible corneal edema when the device is stopped and involve a corneal transplant. Recently, a study showed that the micro-invasive device ab interno Alcon Cypass® (device similar to XEN®) caused an endothelial cell loss that was not significant initially but significant thereafter (48 months) and not acceptable compared to conventional surgery. glaucoma. The damage was proportional to the area of the implant in the anterior chamber and led to the immediate withdrawal of the device from the market. In view of these results and the absence to date of an equivalent study for XEN®, we proposed to conduct this study in order to assess the possible cell loss compared to NPDS.

Tracking Information

NCT #
NCT04781283
Collaborators
Not Provided
Investigators
Principal Investigator: Yves LACHKAR Groupe Hospitalier Paris Saint Joseph