Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma
NCT ID: NCT03904381
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-01-01
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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stand-alone procedure of XEN implantation in phakic eyes
5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
Transconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
Transconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.
stand-alone procedure of XEN implantation in pseudophakic eyes
5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
Transconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
Transconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.
XEN implantation combined with cataract extraction
5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
Transconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
Transconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.
Interventions
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5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
Transconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
Transconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wrocław University of Science and Technology
OTHER
Wroclaw Medical University
OTHER
Responsible Party
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Joanna Przeździecka-Dołyk
Investigator
Principal Investigators
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Marta Misiuk-Hojło, Professor
Role: STUDY_CHAIR
Medical University of Wrocław
Ewa Wałek
Role: PRINCIPAL_INVESTIGATOR
Medical University of Wrocław
Locations
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Department of Ophthalmology
Wroclaw, , Poland
Countries
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References
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Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. doi: 10.1001/archopht.120.9.1136.
Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.
Other Identifiers
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STM.C240.17.037
Identifier Type: -
Identifier Source: org_study_id
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