Primary Open-angle GlaucomaNCT03651336

Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

A study testing ARGOS-IO Sensor Pressure System in people with Primary Open-angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Primary Open-angle Glaucoma
What is being tested?: ARGOS-IO Sensor Pressure System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 4 sitesGermany
Study dates: 15 Aug 2018to 27 Apr 2022
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Who cannot join

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

Klinik für Augenheilkunde, Uniklinik RWTH Aachen
Aachen, 52074
Universitäts-Augenklinik Bochum
Bochum, 44892
Universitätsaugenklinik Magdeburg
Magdeburg, 39120
Universitäts-Augenklinik Tübingen
Tübingen, 72076

Other trials in Germany

About this study

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)

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)

Read the 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.

Conditions: Primary Open-angle Glaucoma
Being tested: ARGOS-IO Sensor Pressure System
Keywords: POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP, Self-monitoring of intraocular pressure
Medical subject headings: Glaucoma, Open-Angle, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARGOS-IO Sensor Pressure SystemDevice
Also called EYEMATE-IO
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

Study groups in NCT03651336
Study group	Role	What they receive
Single-arm longterm follow-up ARGOS-IO Sensor Pressure System	Other	The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02. Receives: Device: ARGOS-IO Sensor Pressure System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Measured: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Performance: Level of Agreement Between GAT and the ARGOS-IO System
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.
Measured: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Performance: Device Malfunctions
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)
Measured: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Secondary outcomes (2)

Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)
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).
Measured: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)
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).
Measured: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201827 Apr 2022

First posted29 Aug 2018
Study start15 Aug 2018
Primary completion27 Apr 2022
Study completion27 Apr 2022

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 Primary Open-angle 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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03651336
Sponsor's protocol ID: ARGOS-03
Other IDs: CIV-18-13-023284
Status last verified: May 2025
First submitted: 20 Aug 2018
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39510809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03651336
Acronym / sponsor ID: ARGOS-03
Conditions: Primary Open-angle Glaucoma
Keywords: POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP, Self-monitoring of intraocular pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Implandata Ophthalmic Products GmbHIndustry (pharma, biotech, devices)
Study start: 15 Aug 2018 (actual)
Primary completion: 27 Apr 2022 (actual)
Study completion: 27 Apr 2022 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 9 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-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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single-arm longterm follow-up ARGOS-IO Sensor Pressure System	Other	Device: ARGOS-IO Sensor Pressure SystemThe ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Key exclusion criteria (1 listed)

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-IO Sensor Pressure SystemAlso: EYEMATE-IOThe 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	Device	Single-arm longterm follow-up ARGOS-IO Sensor Pressure System

Primary outcome

Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
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.
Performance: Level of Agreement Between GAT and the ARGOS-IO System
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.
Performance: Device Malfunctions
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)

2 secondary outcomes

Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)
Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARGOS-IO System	16	12

Primary outcome: Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)

Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07). Count of participants. Unit: Participants

Measure	ARGOS-IO System n = 16
SADEs	0
ADEs	0

Primary outcome: Performance: Level of Agreement Between GAT and the ARGOS-IO System

Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07). Mean (95% Confidence Interval). Unit: mmHg

Measure	ARGOS-IO System n = 16
Value	1.4 (-5.2 to 7.9)

Population analysed: All available pairs of GAT and the ARGOS-IO System IOP measurements.

Primary outcome: Performance: Device Malfunctions

Time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07). Number. Unit: DDs

Measure	ARGOS-IO System n = 7
Reader device (external handheld device)	8
ARGOS-IO sensor	0

Population analysed: All device deficiencies.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Evaluation over 36 months' follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARGOS-IO System	10 of 16 (62.5%)	8 of 16 (50%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39510809Mansouri 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.
Individual participant dataSharing planned: No

Related trials for Primary Open-angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
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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.

Hagen Thieme, Prof. principal investigator

Universitätsaugenklinik Magdeburg

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ARGOS-IO Sensor Pressure System in people with Primary Open-angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 4 sites in Germany.

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 9 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 4 sites in Germany. 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 9 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?

Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) (time frame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)). The study lists 3 primary outcomes in all. 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 NCT03651336, 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 9 May 2025.