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Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

NCT03756662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-01-24

Study results available
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Summary

The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system in the year following the implantation.

Conditions

Interventions

DEVICE

ARGOS-SC suprachoroidal pressure sensor

The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.

Sponsors & Collaborators

  • CRO Dr. med Kottmann GmbH & Co. KG

    collaborator INDUSTRY

  • Implandata Ophthalmic Products GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Szurman, Prof. · Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2021-02-18
Completion
2021-02-18

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756662 on ClinicalTrials.gov