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

NCT03756662 | Completed Results DMC

• 2 other identifiers: ARGOS-SC01CIV-18-07-025065
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 5

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.

Conditions

Glaucoma; Open Angle Glaucoma

Keywords

Non-penetrating glaucoma surgery; Open angle glaucoma; Intraocular pressure measurements; Suprachoroidal pressure sensor; ARGOS-SC

Outcome Measures

Primary Outcomes (1)

• Performance: Level of Agreement Between GAT and the ARGOS-SC System

  Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.

  Day 1 to Day 360 (V02 to V09)

Secondary Outcomes (7)

• Safety: Number of Patients Experiencing a Device-related SAE (SADE)

  Day 0 to Day 360 (V01 [Implantation] to V09)

• 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)

• Performance: Percentage of Measurements Within +/- 5 mmHg

  Day 1 to Day 360 (V02 to V09)

• Performance: Device Malfunctions

  Day 0 to Day 360 (V01 [Implantation] to V09)

• Usability: Implantation Procedure

  Day 1 (V01 [Implantation])

Study Arms (1)

ARGOS-SC Sensor

EXPERIMENTAL

In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.

Device: ARGOS-SC suprachoroidal pressure sensor

Interventions

ARGOS-SC suprachoroidal pressure sensor DEVICE

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

ARGOS-SC Sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to understand the informed consent and willing to participate as evidenced by providing informed consent.
• 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.
• 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.
• Subjects able and willing to attend all scheduled visits and comply with all study procedures

You may not qualify if:

• Contraindications for a non-penetrating glaucoma surgery
• Neovascular glaucoma, primary and secondary angle closure glaucoma
• Condition after previous glaucoma incisional surgery
• IOP \> 40 mmHg
• Myopia (\> -6 dpt) or hypermetropia (\> +4 dpt)
• Axis length \< 22 mm or \> 26 mm
• Acute retinal detachment
• Uncontrolled Diabetes Mellitus (DM) with manifestation of moderate to severe non-proliferative diabetic Retinopathy (DR) or proliferative DR.
• 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
• 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
• 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)
• Existence of other active medical eye implant and/or other active medical implants in the head/neck region
• 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)
• Severe generalized disease resulting in a life expectancy shorter than a year
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• Implandata Ophthalmic Products GmbH: lead
• CRO Dr. med Kottmann GmbH & Co. KG: collaborator

Study Sites (5)

Universitäts-Augenklinik

Bochum, 44892, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

Mainz, 55131, Germany

Location

Augenklinik der LMU München

München, 80336, Germany

Location

Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

Sulzbach, 66280, Germany

Location

Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Lausanne, 1006, Switzerland

Location

Related Publications (2)

• Szurman P, Gillmann K, Seuthe AM, Dick HB, Hoffmann EM, Mermoud A, Mackert MJ, Weinreb RN, Rao HL, Mansouri K; EYEMATE-SC Study Group. EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure. Ophthalmology. 2023 Mar;130(3):304-312. doi: 10.1016/j.ophtha.2022.09.021. Epub 2022 Oct 3.

  PMID: 36202141 RESULT

• Szurman P, Mansouri K, Dick HB, Mermoud A, Hoffmann EM, Mackert M, Weinreb RN, Rao HL, Seuthe AM; EYEMATE-SC study group. Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial. Br J Ophthalmol. 2023 Apr;107(4):518-524. doi: 10.1136/bjophthalmol-2021-320023. Epub 2021 Nov 12.

  PMID: 34772665 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Implandata Ophthalmic Products

clinical@implandata.com

+49 (0) 511 - 2204 2580

Study Officials

• Peter Szurman, Prof.

  Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single arm, multicenter

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 19, 2018
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (4)