Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wroclaw Medical University
• Collaborator: Wrocław University of Science and Technology
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• diagnosis of primary open angle glaucoma

• trabecular meshwork visible in gonioscopy

• medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg

• taking 1 to 5 IOP-lowering medications

• area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)

• signed inform consent

Exclusion Criteria:

• angle closure glaucoma

• secondary open angle glaucoma

• previous glaucoma shunt/valve in the target quadrant

• presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

• active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)

• active iris neovascularization or neovascularization of the iris within 6 months of the surgical date

• anterior chamber intraocular lens

• presence of 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

• previous photorefractive keratectomy