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Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)

NCT03904381•Wroclaw Medical University

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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)
+3 more criteria

Locations (1)

Department of Ophthalmology

Wroclaw, Poland

Key Dates

Start Date

January 1, 2016

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2025

Last Updated

March 29, 2022

Enrollment

100

ESTIMATED participants

Conditions

Open-angle Glaucoma

Interventions

5-fluorouracil

DRUG

Transconjunctival needling

PROCEDURE

Transconjunctival revision

PROCEDURE

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

NCT06267274

Open-angle GlaucomaOcular Hypertension

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COMPLETEDPHASE3

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

NCT03850782

Open-Angle GlaucomaOcular Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

PASCAL Trabeculoplasty

PRESERFLO® MicroShunt Extension Study

Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity

Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost