NCT04773106

Brief Summary

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
2 countries

5 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

February 20, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 18, 2025

Completed
Last Updated

May 18, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

February 21, 2021

Results QC Date

March 25, 2025

Last Update Submit

April 24, 2025

Conditions

GlaucomaOpen Angle Glaucoma

Keywords

Non-penetrating glaucoma surgeryOpen angle glaucomaIntraocular pressure measurementsSuprachoroidal pressure sensorARGOS-SC

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 360 to Day 1080 (V09 to V13)

Secondary Outcomes (6)

  • Safety: Number of Patients Experiencing a Device-related SAE (SADE)

    Day 360 to Day 1080 (V09 to V13)

  • Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)

    Day 360 to Day 1080 (V09 to V13)

  • Performance: Percentage of Measurements Within +/- 5 mmHg

    Day 360 to Day 1080 (V09 to V13)

  • Performance: Device Malfunctions

    Day 360 to Day 1080 (V09 to V13)

  • Usability: User Acceptance at the Investigational Site

    Day 1080 (V13)

  • +1 more secondary outcomes

Study Arms (1)

ARGOS-SC Sensor

OTHER

The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.

Device: ARGOS-SC suprachoroidal pressure sensor

Interventions

ARGOS-SC suprachoroidal pressure sensorDEVICE

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.

Also known as: EYEMATE-SC
ARGOS-SC Sensor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitäts-Augenklinik Bochum

Bochum, 44892, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

Mainz, 55131, Germany

Location

Augenklinik der LMU München

München, 80336, Germany

Location

Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

Sulzbach, 66280, Germany

Location

Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Lausanne, 1006, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 39892748RESULT

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

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

Study Officials

  • Peter Szurman, Prof.

    Knappschaftsklinikum Saar GmbH

    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

February 21, 2021

First Posted

February 26, 2021

Study Start

February 20, 2020

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

May 18, 2025

Results First Posted

May 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)DE(4)