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

Not Applicable

Completed

• Conditions: Glaucoma; Open Angle Glaucoma

• Registration Number: NCT03756662
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-11-19
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Primary Completion: 2021-02-18
• Study Completion: 2021-02-18
• Results First Submitted: 2023-03-07
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Results First Posted: 2025-01-24
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance: Level of Agreement Between GAT and the ARGOS-SC System	Day 1 to Day 360 (V02 to V09)	Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.

Secondary Outcome Measures

Name	Time	Method
Safety: Number of Patients Experiencing a Device-related SAE (SADE)	Day 0 to Day 360 (V01 [Implantation] to V09)	Number of patients experiencing a device-related SAE (SADE).
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)	Day 0 to Day 360 (V01 [Implantation] to V09)	Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Performance: Percentage of Measurements Within +/- 5 mmHg	Day 1 to Day 360 (V02 to V09)	Concordance of the ARGOS-SC\<\>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT \& the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 70% agreement of the total number of comparisons between +/-5 mmHg. The first column presents the overall data and the second column presents data from 3 months postoperatively onwards.
Performance: Device Malfunctions	Day 0 to Day 360 (V01 [Implantation] to V09)	Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Usability: Implantation Procedure	Day 1 (V01 [Implantation])	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). Overall Number of Participant Analyzed represents the 7 surgeons who provided feedback via a structured questionnaire. The score 7 represents a greater user acceptance.
Usability: User Acceptance at the Investigational Site	Day 1 to Day 360 (V02 to V09)	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). Overall Number of Participants Analyzed represents the 12 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.
Usability: User Acceptance at Home	Day 1 to Day 360 (V02 to V09)	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). The score 7 represents a greater user acceptance.

Trial Locations

Locations (5)

Augenklinik der LMU München; 🇩🇪 München, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik; 🇩🇪 Mainz, Germany

Universitäts-Augenklinik; 🇩🇪 Bochum, Germany

Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach; 🇩🇪 Sulzbach, Germany

Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi; 🇨🇭 Lausanne, Switzerland