Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03651336|
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : July 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Primary Open-angle Glaucoma||Device: ARGOS-IO Sensor Pressure System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||August 15, 2018|
|Actual Primary Completion Date :||April 27, 2022|
|Actual Study Completion Date :||April 27, 2022|
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.
Device: 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 Name: EYEMATE-IO
- Safety measured by Incidence of medical-device related adverse events and serious adverse events [ Time Frame: 3 years ]The primary objective of this clinical trial is to evaluate the long-term safety and tolerability of the ARGOS-IO pressure sensor under consideration of incidence, nature, severity and seriousness of observed medical device related adverse and serious adverse events.An AE is considered to be device-related if there is at least a possible relationship to the medical device according to the rating of the investigator.
- Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit. [ Time Frame: 3 years ]IOP measured in mmHg
- Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit. [ Time Frame: 3 Years ]IOP measured in mmHg
- Incidence of observed device malfunctions and nature of device malfunction [ Time Frame: 3 years ]A device malfunction is e.g. difference of more than 5 mmHg between ARGOS-IO and GAT, readout error of the Mesograph because of measurements outside -2 and +70mmHG.
- Patient's compliance in IOP self-monitoring [ Time Frame: 3 years ]Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)
- Impact of IOP self-monitoring on glaucoma progression [ Time Frame: 3 years ]Visual field (db), cup/disc ratio, OCT of the optic nerve (µm) and the IOP (mmHg) has to be compared together to evaluate glaucoma progression
- Incidence in glaucoma medication change [ Time Frame: 3 years ]Number of glaucoma medication
- Number of unscheduled visits due to self-measured increased intraocular pressure [ Time Frame: 3 years ]The patients decide to come for a visit by their own due to any reason. This will be documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651336
|Klinik für Augenheilkunde, Uniklinik RWTH Aachen|
|Aachen, Germany, 52074|
|Bochum, Germany, 44892|
|Magdeburg, Germany, 39120|
|Tübingen, Germany, 72076|
|Principal Investigator:||Hagen Thieme, Prof.||Universitätsaugenklinik Magdeburg|