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

NCT04750447 | Unknown FDA Device

• 1 other identifier: 1035
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 lowers intraocular pressure (IOP) by bypassing the natural outflow pathway of aqueous. Currently three Xen models have been developed: 45, 63, and 140 um internal lumen diameters.2 XEN45 ab interno gelatin stent was the first to be approved for clinical use in Canada.3 A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy.4 Amongst the main advantages of this device is the ability to create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound healing and potentially limiting bleb failure. Recently, the XEN63 ab interno gelatin stent was approved by Health Canada for clinical use in Canada. Being a new device, to date, no study has examined the effect of XEN63 ab interno gelatin stent on anti-glaucoma drops burden and IOP. The aim of this study is to investigate the safety and efficacy of the XEN63 ab interno gelatin stent to provide insights for ophthalmologists who will want to add this technique to their practice.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (3)

• Complete Success

  Intraocular Pressure: 6-17 mmHg and on no glaucoma medications at least 1 month after surgery with no reoperation using the Goldmann Applanation Tonometer..

  1 month post op to post op month 12

• Absence of complications

  Absence of the following complications as reported during slitlamp examination: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, blebitis/endophthalmitis

  post op day 1 to post op month 12

• Qualified Success

  a. 'Complete success' criteria except that Intraocular Pressure (IOP) can be above IOP thresholds, and then reduced to within the 'Complete criteria' by medications or laser in 3 visits or less as measured by Goldmann Applanation Tonometry.

  post op month 1 to post op month 12

Study Arms (1)

Open Angle Glaucoma

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

Device: XEN 63

Interventions

XEN 63 DEVICE

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.

Open Angle Glaucoma

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo Xen 63 implantation for open angle glaucoma with or without cataract surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prism Eye Institute: lead
• Allergan: collaborator

Study Sites (1)

Prism Eye Institute

Oakville, Ontario, L6H 0J8, Canada

RECRUITING

Related Publications (3)

• Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.

  PMID: 28237137 BACKGROUND

• Green W, Lind JT, Sheybani A. Review of the Xen Gel Stent and InnFocus MicroShunt. Curr Opin Ophthalmol. 2018 Mar;29(2):162-170. doi: 10.1097/ICU.0000000000000462.

  PMID: 29319544 BACKGROUND

• Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7.

  PMID: 28601250 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Iqbal Ahmed, MD

  Prism Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronaldo Santiago, MD

CONTACT

905-4563937; ronaldo.santiago@prismeye.ca

Ramzi Jumaa, MD

CONTACT

905-456-3937; ramzi3@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 11, 2021
• Study Start: November 9, 2020
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)