GlaucomaNCT04773106
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
A study testing ARGOS-SC suprachoroidal pressure sensor in people with Glaucoma and Open Angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open Angle Glaucoma
- What is being tested?
- ARGOS-SC suprachoroidal pressure sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Feb 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
Who cannot join
- N/A
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Universitäts-Augenklinik Bochum
Bochum, 44892
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, 55131
Augenklinik der LMU München
München, 80336
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
Sulzbach, 66280
Switzerland1 site
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, 1006
About this study
Official title: Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
Read the detailed description
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01_FU study.
The sensor was always implanted in one eye only which will be the study eye.
- Conditions
- Glaucoma, Open Angle Glaucoma
- Being tested
- ARGOS-SC suprachoroidal pressure sensor
- Keywords
- Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS-SC suprachoroidal pressure sensorDevice
Also called EYEMATE-SC
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.
| Study group | Role | What they receive |
|---|---|---|
| ARGOS-SC Sensor | Other | The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study. Receives: Device: ARGOS-SC suprachoroidal pressure sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
Measured: Day 360 to Day 1080 (V09 to V13)
Secondary outcomes (6)
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE)
Measured: Day 360 to Day 1080 (V09 to V13)
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Measured: Day 360 to Day 1080 (V09 to V13)
Performance: Percentage of Measurements Within +/- 5 mmHg
Concordance of the ARGOS-SC<>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT \& the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 65% agreement of the total number of comparisons between +/-5 mmHg.
Measured: Day 360 to Day 1080 (V09 to V13)
Performance: Device Malfunctions
The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor.
Measured: Day 360 to Day 1080 (V09 to V13)
Usability: User Acceptance at the Investigational Site
User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participants Analyzed represents the 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.
Measured: Day 1080 (V13)
Usability: User Acceptance at Home
User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.
Measured: Day 1080 (V13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start20 Feb 2020
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implandata Ophthalmic Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Peter Szurman, Prof., Principal investigator, Knappschaftsklinikum Saar GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773106
- Sponsor's protocol ID
- ARGOS-SC01_Follow-up
- Other IDs
- CIV-19-11-030784
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2021
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39892748
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)
- ClinicalTrials.gov ID
- NCT04773106
- Acronym / sponsor ID
- ARGOS-SC01_Follow-up
- Conditions
- Glaucoma, Open Angle Glaucoma
- Keywords
- Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Implandata Ophthalmic Products GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
Detailed description
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01_FU study.
The sensor was always implanted in one eye only which will be the study eye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARGOS-SC Sensor | Other | Device: ARGOS-SC suprachoroidal pressure sensorThe ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGOS-SC suprachoroidal pressure sensorAlso: EYEMATE-SCThe 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. | Device | ARGOS-SC Sensor |
Primary outcome
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Time frame: Day 360 to Day 1080 (V09 to V13)
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
6 secondary outcomes
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Time frame: Day 360 to Day 1080 (V09 to V13)
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
Time frame: Day 360 to Day 1080 (V09 to V13)
Performance: Percentage of Measurements Within +/- 5 mmHg
Time frame: Day 360 to Day 1080 (V09 to V13)
Performance: Device Malfunctions
Time frame: Day 360 to Day 1080 (V09 to V13)
Usability: User Acceptance at the Investigational Site
Time frame: Day 1080 (V13)
Usability: User Acceptance at Home
Time frame: Day 1080 (V13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39892748Micheletti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Szurman, Prof. principal investigator
Knappschaftsklinikum Saar GmbH
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARGOS-SC suprachoroidal pressure sensor in people with Glaucoma and Open Angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance: Level of Agreement Between GAT and the ARGOS-SC System (time frame: Day 360 to Day 1080 (V09 to V13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.