Performance and Safety of the ARGOS-SC01 Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery (ARGOS-SC01)

November 1, 2021 updated by: Implandata Ophthalmic Products GmbH

A Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. Subjects will be followed up at regular intervals for one year following implantation to collect safety and performance information. Enrollment will be halted at every serious adverse device event (SADE).

The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery and is used in conjunction with the hand-held MESOGRAPH reading device to telemetrically measure the intraocular pressure (IOP) of the implanted eye.

The sample size calculation was based on the study's dual purpose of establishing safety and comparability of IOP measurements with the ARGOS-SC system to those made with GAT and DCT. IOP measurements will be made with all devices at various time points, resulting in a within individual control for IOP variables. Based on these calculations (performance, safety) and considering possible drop-outs, the exploratory investigation will enroll 24 patients. The minimum number of measurements required to hold the performance claim is approx. 120. With multiple (>8) measurements with either method (ARGOS, GAT) per patient, a sufficient number of paired measurements (in total >>120 measurement pairs) will be available to show equivalence of the methods (primary objective).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44892
        • Universitäts-Augenklinik
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
      • München, Germany, 80336
        • Augenklinik der LMU München
      • Sulzbach, Germany, 66280
        • Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
  • Switzerland
      • Lausanne, Switzerland, 1006
        • Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects able to understand the informed consent and willing to participate as evidenced by providing informed consent.
  2. Male or female aged ≥ 18 years on the day of screening Female subjects of childbearing potential (not surgically sterilized or more than one year post-menopausal) must be willing to use adequate contraception throughout the trial and must have a negative pregnancy test (urine beta-hCG) within 24 hours prior to ARGOS-SC pressure sensor implantation.
  3. Diagnosis of open angle glaucoma requiring a non-penetrating glaucoma surgery (NPGS). The medical indication for a non-penetrating glaucoma surgery must be given irrespective of the study participation. Potential study patients will be solicited for participation in the clinical trial only after the patient has given consent to the non-penetrating glaucoma operation.
  4. Subjects able and willing to attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

  1. Contraindications for a non-penetrating glaucoma surgery

    • Neovascular glaucoma, primary and secondary angle closure glaucoma
    • Condition after previous glaucoma incisional surgery
    • IOP > 40 mmHg
  2. Myopia (> -6 dpt) or hypermetropia (> +4 dpt)
  3. Axis length < 22 mm or > 26 mm
  4. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
  5. Acute retinal detachment
  6. Uncontrolled Diabetes Mellitus (DM) with manifestation of moderate to severe non-proliferative diabetic Retinopathy (DR) or proliferative DR.
  7. History or evidence of severe active inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-SC implantation
  8. Ocular surgery procedure(s) (excluding selective laser trabeculoplasty and peripheral iridotomy) within 6 months (cataract surgery within 3 months) prior to ARGOS-SC implantation in the study eye that can affect the assessment of IOP by Goldmann Applanation tonometry
  9. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann Applanation tonometry/Pascal Dynamic Contour Tonometry (e.g. choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)
  10. Existence of other active medical eye implant and/or other active medical implants in the head/neck region
  11. Difficulties or complications during NPGS procedure or implantation of ARGOS-SC sensor, as assessed by surgeon (e.g. perforation of trabeculo-descement's membrane; excessive aqueous filtration through TDM leading to shallow anterior chamber; excessive bleeding; choroidal detachment)
  12. Severe generalized disease resulting in a life expectancy shorter than a year
  13. Currently pregnant or breastfeeding
  14. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
  15. Patients who are not suitable for the study based on the surgeon's evaluation
  16. Patients unable or unwilling to understand or comply with required study procedures
  17. Patients with psychiatric disorders influencing their judgement or autonomy
  18. Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
  19. Enrollment of the fellow eye in this clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance
Time Frame: Day 1 to Day 360
Level of Agreement between measurements made using GAT, Pascal DCT and the ARGOS-SC system (IOP in mmHg)
Day 1 to Day 360

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Number of patients experiencing a device-related SAE (SADE)
Time Frame: During implantation and 12 months follow-up
Number of patients experiencing a device-related SAE (SADE)
During implantation and 12 months follow-up
Safety: Incidence, nature, severity and seriousness of observed adverse events and adverse device events
Time Frame: During implantation and 12 months follow-up
Incidence, nature, severity and seriousness of observed adverse events and adverse device events
During implantation and 12 months follow-up
Performance
Time Frame: Day 2 to Day 360
Repeatability of the ARGOS-SC measurement
Day 2 to Day 360
Performance
Time Frame: During implantation and 12 months follow-up
Incidence, nature and seriousness of observed device malfunctions
During implantation and 12 months follow-up
Utility
Time Frame: Day 1
User acceptance of the ARGOS-SC implantation procedure by means of evaluation of implantation procedure questionnaires (surgeons) on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
Day 1
Utility
Time Frame: Day 2 to Day 360
User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
Day 2 to Day 360
Utility
Time Frame: Day 2 to Day 360
User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
Day 2 to Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Implandata Ophthalmic Products GmbH

Collaborators

CRO Dr. med. Kottmann GmbH & Co. KG

Investigators

  • Principal Investigator: Peter Szurman, Prof., Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2018

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGOS-SC01
  • CIV-18-07-025065 (Registry Identifier: Eudamed)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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