NCT Number: NCT03651336
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Klinik für Augenheilkunde, Uniklinik RWTH Aachen, Aachen, Germany
This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: EYEMATE-IO
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).
Implandata Ophthalmic Products GmbH
Industry
A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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