Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
NCT ID: NCT02006693
Last Updated: 2019-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
199 participants
INTERVENTIONAL
2013-12-05
2017-01-26
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
PARALLEL
TREATMENT
NONE
Study Groups
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XEN® Gel Stent
The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
XEN® Gel Stent
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
XEN® Gel Stent with Cataract Surgery
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Cataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.
Interventions
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XEN® Gel Stent
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
Cataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants are taking at least one and no more than four topical IOP-lowering medications.
Exclusion Criteria
* Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
* Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
18 Years
ALL
No
Sponsors
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AqueSys, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vanessa Vera, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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University of Graz
Graz, , Austria
University Augenklinik Salzburg
Salzburg, , Austria
Vienna University
Vienna, , Austria
University Hospitals Leuven
Leuven, , Belgium
University Eye Clinic Bochum-Langendreer
Bochum, , Germany
Klinik für Augenheilkunde
Frankfurt, , Germany
Klinik fur Augenheilkunde
Neubrandenburg, , Germany
University of Pisa
Pisa, , Italy
Clinica Oculistica, Universita' di Torino
Torino, , Italy
Integrated University Hospital of Verona
Verona, , Italy
Ophthalmology Department of the Military Health Service Institute
Warsaw, , Poland
Hospital Meixeiro Servicio de Ofthalmologia
Vigo, Pontevedra, Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Principe de Asturias
Madrid, , Spain
University of Geneva
Geneva, , Switzerland
Maidstone Hospital Eye, Ear and Mouth Unit
Maidstone, Kent, United Kingdom
Birmingham Midland Eye Theaters
Birmingham, West Midlands, United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
Pinderfields Hospital
Wakefield, , United Kingdom
Unidad Oftalmologica de Caracas
Caracas, , Venezuela
Countries
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References
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Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.
Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
Other Identifiers
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MS-001
Identifier Type: -
Identifier Source: org_study_id
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