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

Wroclaw Medical University

Status and phase: Active, not recruiting; Phase 4

Conditions: Open-angle Glaucoma

Treatments: Drug: 5-fluorouracil; Procedure: Transconjunctival revision; Procedure: Transconjunctival needling

Study type: Interventional

Funder types: Other

Identifiers

NCT03904381

STM.C240.17.037

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

stand-alone procedure of XEN implantation in phakic eyes

Active Comparator group

Treatment:

Drug: 5-fluorouracil

Procedure: Transconjunctival revision

Procedure: Transconjunctival needling

stand-alone procedure of XEN implantation in pseudophakic eyes

Active Comparator group

Treatment:

Drug: 5-fluorouracil

Procedure: Transconjunctival revision

Procedure: Transconjunctival needling

XEN implantation combined with cataract extraction

Active Comparator group

Treatment:

Drug: 5-fluorouracil

Procedure: Transconjunctival revision

Procedure: Transconjunctival needling