Back to resultsLong-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Primary Purpose
Primary Open-angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ARGOS-IO Sensor Pressure System
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Open-angle Glaucoma focused on measuring POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP, Self-monitoring of intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.
Exclusion Criteria:
- N/A
Sites / Locations
- Klinik für Augenheilkunde, Uniklinik RWTH Aachen
- Universitäts-Augenklinik Bochum
- Universitätsaugenklinik Magdeburg
- Universitäts-Augenklinik Tübingen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-arm longterm follow-up ARGOS-IO Sensor Pressure System
Arm Description
The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.
Outcomes
Primary Outcome Measures
Safety measured by Incidence of medical-device related adverse events and serious adverse events
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.
IOP measured in mmHg
Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit.
IOP measured in mmHg
Incidence of observed device malfunctions and nature of device malfunction
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.
Secondary Outcome Measures
Patient's compliance in IOP self-monitoring
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
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
Number of glaucoma medication
Number of unscheduled visits due to self-measured increased intraocular pressure
The patients decide to come for a visit by their own due to any reason. This will be documented.
Full Information
NCT ID
NCT03651336
First Posted
August 20, 2018
Last Updated
July 11, 2022
Sponsor
Implandata Ophthalmic Products GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03651336
Brief Title
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Implandata Ophthalmic Products GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP, Self-monitoring of intraocular pressure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm longterm follow-up ARGOS-IO Sensor Pressure System
Arm Type
Other
Arm Description
The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.
Intervention Type
Device
Intervention Name(s)
ARGOS-IO Sensor Pressure System
Other Intervention Name(s)
EYEMATE-IO
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety measured by Incidence of medical-device related adverse events and serious adverse events
Description
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.
Time Frame
3 years
Title
Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit.
Description
IOP measured in mmHg
Time Frame
3 years
Title
Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit.
Description
IOP measured in mmHg
Time Frame
3 Years
Title
Incidence of observed device malfunctions and nature of device malfunction
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Patient's compliance in IOP self-monitoring
Description
Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)
Time Frame
3 years
Title
Impact of IOP self-monitoring on glaucoma progression
Description
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
Time Frame
3 years
Title
Incidence in glaucoma medication change
Description
Number of glaucoma medication
Time Frame
3 years
Title
Number of unscheduled visits due to self-measured increased intraocular pressure
Description
The patients decide to come for a visit by their own due to any reason. This will be documented.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagen Thieme, Prof.
Organizational Affiliation
Universitätsaugenklinik Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Augenheilkunde, Uniklinik RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitäts-Augenklinik Bochum
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsaugenklinik Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitäts-Augenklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
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