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

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750447
• Other study ID #: 1035
• Status: Recruiting
• Start date: November 9, 2020
• Est. completion date: June 9, 2023

Study information

• Verified date: September 2022
• Source: Prism Eye Institute
• Contact: Ronaldo Santiago, MD
• Phone: 905-4563937
• Email: ronaldo.santiago[@]prismeye.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 glaucoma surgery with XEN63 implantation will be enrolled and followed for up to 12 months postoperatively. Enrollees will follow the standard of care visits (pre-op, post-op day 1, post-op week 1 and post op month 1) where they will undergo a full eye exam (visual acuity, refraction, slit lamp exam and intraocular pressure measurement). In addition to the standard of care visit, enrollees will have 2 additional visits (post-op month 6 and post-op month 12) where they will undergo a full eye exam. Additional tests include a Visual Field assessment and Endothelial cell count on their pre-op visit, post-operative month visit 6 and post-op month 12 visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle

Intervention

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.

Locations

Country	Name	City	State
Canada	Prism Eye Institute	Oakville	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Prism Eye Institute	Allergan

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Ophthalmology. 2018 Mar;125(3):463. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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