Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C

UnknownOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

June 9, 2023

Study Completion Date

June 9, 2023

Conditions
Glaucoma, Open-Angle
Interventions
DEVICE

XEN 63

The Xen gelatin microstent (Allergan, CA, USA) is a 6mm gelatin tube used in microinvasive glaucoma surgery (MIGS) to create a bleb. A bleb is a fluid filled blister located in the tissue covering the white portion of the eye (the conjunctiva) created after glaucoma surgery. The bleb allows the eye pressure (intraocular pressure - IOP) to be lowered by bypassing the natural pathways by which the fluid called aqueous leaves the eye and redirecting it towards the bleb to be absorbed by other pathways. Amongst the main advantages of this device is the ability to create a bleb without disrupting tissue unlike other methods of glaucoma surgery (e.g., trabeculectomy). This decreases the amount of wound healing and scarring, and potentially limiting bleb failure.

Trial Locations (1)

L6H 0J8

RECRUITING

Prism Eye Institute, Oakville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Prism Eye Institute

OTHER

NCT04750447 - Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C | Biotech Hunter | Biotech Hunter