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

Phase 4UnknownNCT03904381

Wroclaw Medical University100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Open-angle Glaucoma

Interventions

5-fluorouracilDRUG

5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Transconjunctival needlingPROCEDURE

Transconjunctival needling was administered according to predetermined criteria.

Transconjunctival revisionPROCEDURE

Transconjunctival revision was administered according to predetermined criteria.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Ophthalmology

Wroclaw, Poland

Outcomes

Primary Outcomes

Unqualified success

Unqualified success of glaucoma treatment, defined as a postoperative IOP \<18 mmHg and \>20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

Time frame: 5 years

Secondary Outcomes

Qualified success score A

Qualified success of glaucoma treatment, defined as a postoperative IOP \<21 mmHg and \>20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

Time frame: 5 years

Qualified success score B

Qualified success of glaucoma treatment, defined as a postoperative IOP \< 18 mmHg and \>20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

Time frame: 5 years

Qualified success score C

Qualified success of glaucoma treatment, defined as a postoperative IOP ≤15 mmHg and \>40% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

Time frame: 5 years

Data from ClinicalTrials.gov

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