Status:
UNKNOWN
Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
Lead Sponsor:
Prism Eye Institute
Collaborating Sponsors:
Allergan
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
30-90 years
Brief Summary
The Xen gelatin microstent (Allergan, CA, USA) is a 6mm hydrophobic, bleb-forming microinvasive glaucoma surgery (MIGS).1 Creation of a filtering bleb through the gel stent and under the conjunctiva l...
Detailed Description
• This is a prospective, single-arm, open-label clinical trial designed to demonstrate the safety and IOP-lowering effectiveness of XEN 63. Approximately 29 patients who are scheduled to undergo glauc...
Eligibility Criteria
Inclusion
- Patients aged 30-90 Primary open angle glaucoma on maximum tolerated medical therapy Going to receive XEN63 ab interno gelatin stent with or without MMC in study eye ± cataract surgery
Exclusion
- Other forms of glaucoma
- Previous glaucoma shunt/valve in the target quadrant of study eye
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant of study eye
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date
- Presence of anterior chamber intraocular lens, intraocular silicone oil, vitreous present in the anterior chamber, impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
- Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde), history of dermatologic keloid formation.
- Prior CPC, corneal graft (PKP, DALK, DSAEK, DMEK)
- Other forms of combined surgery (cornea, retina) besides cataract surgery
Key Trial Info
Start Date :
November 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 9 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04750447
Start Date
November 9 2020
End Date
June 9 2023
Last Update
September 28 2022
Active Locations (1)
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1
Prism Eye Institute
Oakville, Ontario, Canada, L6H 0J8