Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
NCT ID: NCT03651336
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-08-15
2022-04-27
Brief Summary
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Detailed Description
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From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.
Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.
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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Single-arm longterm follow-up ARGOS-IO Sensor Pressure System
The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.
ARGOS-IO Sensor Pressure System
The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02
Interventions
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ARGOS-IO Sensor Pressure System
The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
ALL
No
Sponsors
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Implandata Ophthalmic Products GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Hagen Thieme, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsaugenklinik Magdeburg
Locations
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Klinik für Augenheilkunde, Uniklinik RWTH Aachen
Aachen, , Germany
Universitäts-Augenklinik Bochum
Bochum, , Germany
Universitätsaugenklinik Magdeburg
Magdeburg, , Germany
Universitäts-Augenklinik Tübingen
Tübingen, , Germany
Countries
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References
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Mansouri K, Rao HL, Weinreb RN. Nyctohemeral effects of topical beta-adrenoceptor blocking agents measured with an intraocular telemetry sensor. Br J Ophthalmol. 2025 Apr 22;109(5):582-586. doi: 10.1136/bjo-2023-324760.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIV-18-13-023284
Identifier Type: OTHER
Identifier Source: secondary_id
ARGOS-03
Identifier Type: -
Identifier Source: org_study_id
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