NCT03651336

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 9, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

August 20, 2018

Results QC Date

March 20, 2025

Last Update Submit

May 8, 2025

Conditions

Primary Open-angle Glaucoma

Keywords

POAGPrimary Open Angle GlaucomaCataractIntraocular PressureIntraocular Pressure Sensor SystemIOPSelf-monitoring of intraocular pressure

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

  • Performance: Device Malfunctions

    Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)

    Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Secondary Outcomes (2)

  • Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)

    Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

  • Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)

    Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Study Arms (1)

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.

Device: ARGOS-IO Sensor Pressure System

Interventions

ARGOS-IO Sensor Pressure SystemDEVICE

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

Also known as: EYEMATE-IO
Single-arm longterm follow-up ARGOS-IO Sensor Pressure System

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Klinik für Augenheilkunde, Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Universitäts-Augenklinik Bochum

Bochum, 44892, Germany

Location

Universitätsaugenklinik Magdeburg

Magdeburg, 39120, Germany

Location

Universitäts-Augenklinik Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 39510809DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleCataract

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesLens Diseases

Results Point of Contact

Title
Clinical Study Manager
Organization
Implandata Ophthalmic Products
clinical@implandata.com
+49 (0) 511 - 2204 2580

Study Officials

  • Hagen Thieme, Prof.

    Universitätsaugenklinik Magdeburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 29, 2018

Study Start

August 15, 2018

Primary Completion

April 27, 2022

Study Completion

April 27, 2022

Last Updated

May 9, 2025

Results First Posted

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)