Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
NCT ID: NCT04773106
Last Updated: 2025-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2020-02-20
2023-03-02
Brief Summary
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Detailed Description
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The sensor was always implanted in one eye only which will be the study eye.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ARGOS-SC Sensor
The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.
ARGOS-SC suprachoroidal pressure sensor
The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.
Interventions
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ARGOS-SC suprachoroidal pressure sensor
The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CRO Dr. med Kottmann GmbH & Co. KG
INDUSTRY
Implandata Ophthalmic Products GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Szurman, Prof.
Role: PRINCIPAL_INVESTIGATOR
Knappschaftsklinikum Saar GmbH
Locations
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Universitäts-Augenklinik Bochum
Bochum, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, , Germany
Augenklinik der LMU München
München, , Germany
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
Sulzbach, , Germany
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, , Switzerland
Countries
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References
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Micheletti E, Mansouri K, Dick HB, Hoffmann EM, Mackert MJ, Weinreb RN, Szurman P; EYEMATE-SC Study Group. Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology. 2025 Jul;132(7):775-784. doi: 10.1016/j.ophtha.2025.01.021. Epub 2025 Jan 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIV-19-11-030784
Identifier Type: REGISTRY
Identifier Source: secondary_id
ARGOS-SC01_Follow-up
Identifier Type: -
Identifier Source: org_study_id
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