Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

NCT ID: NCT04773106

Last Updated: 2025-05-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2023-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Open Angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARGOS-SC Sensor

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

Group Type OTHER

ARGOS-SC suprachoroidal pressure sensor

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARGOS-SC suprachoroidal pressure sensor

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EYEMATE-SC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CRO Dr. med Kottmann GmbH & Co. KG

INDUSTRY

Sponsor Role collaborator

Implandata Ophthalmic Products GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Szurman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Knappschaftsklinikum Saar GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitäts-Augenklinik Bochum

Bochum, , Germany

Site Status

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

Mainz, , Germany

Site Status

Augenklinik der LMU München

München, , Germany

Site Status

Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

Sulzbach, , Germany

Site Status

Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 39892748 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIV-19-11-030784

Identifier Type: REGISTRY

Identifier Source: secondary_id

ARGOS-SC01_Follow-up

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

aICP in Glaucoma and Papilledema
NCT02410148 UNKNOWN NA