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

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ClinicalTrials.gov Identifier: NCT03756662
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
CRO Dr. med. Kottmann GmbH & Co. KG
Information provided by (Responsible Party):
Implandata Ophthalmic Products GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Open Angle Glaucoma Device: ARGOS-SC suprachoroidal pressure sensor Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, single arm, multicenter
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Performance [ Time Frame: Day 2 to Day 360 ]
    Repeatability of the ARGOS-SC measurement

  4. Performance [ Time Frame: During implantation and 12 months follow-up ]
    Incidence, nature and seriousness of observed device malfunctions

  5. 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)

  6. 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)

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756662


Contacts
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Contact: Janina Hadeler 004917661944731 jhadeler@implandata.com

Locations
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Germany
Universitäts-Augenklinik Not yet recruiting
Bochum, Germany, 44892
Contact: Burkhard Dick, Prof.    0049 0234 2990    Burkhard.Dick@kk-bochum.de   
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach Recruiting
Sulzbach, Germany, 66280
Contact: Peter Szurman, Prof.    0049 6897 574 1119    peter.szurman@googlemail.com   
Switzerland
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi Not yet recruiting
Lausanne, Switzerland, 1006
Contact: Kaweh Mansouri, Prof    021 619 37 42    kwmansouri@gmail.com   
Sponsors and Collaborators
Implandata Ophthalmic Products GmbH
CRO Dr. med. Kottmann GmbH & Co. KG
Investigators
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Principal Investigator: Peter Szurman, Prof. Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

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Responsible Party: Implandata Ophthalmic Products GmbH
ClinicalTrials.gov Identifier: NCT03756662     History of Changes
Other Study ID Numbers: ARGOS-SC01
CIV-18-07-025065 ( Registry Identifier: Eudamed )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Implandata Ophthalmic Products GmbH:
Non-penetrating glaucoma surgery
Open angle glaucoma
Intraocular pressure measurements
Suprachoroidal pressure sensor
ARGOS-SC

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases