GlaucomaARGOS-SC01NCT03756662
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
A study testing ARGOS-SC suprachoroidal pressure sensor in people with Glaucoma and Open Angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open Angle Glaucoma
- What is being tested?
- ARGOS-SC suprachoroidal pressure sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Nov 2018to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- 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
- 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
- Patients who are not suitable for the study based on the surgeon's evaluation
- Patients unable or unwilling to understand or comply with required study procedures
- Patients with psychiatric disorders influencing their judgement or autonomy
- 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.
- Enrollment of the fellow eye in this clinical study
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Universitäts-Augenklinik
Bochum, 44892
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, 55131
Augenklinik der LMU München
München, 80336
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
Sulzbach, 66280
Switzerland1 site
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, 1006
About this study
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
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.
Read the 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).
- Conditions
- Glaucoma, Open Angle Glaucoma
- Being tested
- ARGOS-SC suprachoroidal pressure sensor
- Keywords
- Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS-SC suprachoroidal pressure sensorDevice
The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ARGOS-SC suprachoroidal pressure sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 360 (V02 to V09)
Secondary outcomes (7)
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE).
Measured: 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)
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Measured: Day 0 to Day 360 (V01 [Implantation] to V09)
Performance: Percentage of Measurements Within +/- 5 mmHg
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.
Measured: Day 1 to Day 360 (V02 to V09)
Performance: Device Malfunctions
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Measured: Day 0 to Day 360 (V01 [Implantation] to V09)
Usability: Implantation Procedure
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.
Measured: Day 1 (V01 [Implantation])
Usability: User Acceptance at the Investigational Site
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.
Measured: Day 1 to Day 360 (V02 to V09)
Usability: User Acceptance at Home
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.
Measured: Day 1 to Day 360 (V02 to V09)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start19 Nov 2018
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single arm, multicenter
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implandata Ophthalmic Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Peter Szurman, Prof., Principal investigator, Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756662
- Sponsor's protocol ID
- ARGOS-SC01
- Other IDs
- CIV-18-07-025065
- Acronym
- ARGOS-SC01
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2018
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36202141Szurman 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.
PubMed 34772665
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03756662
- Acronym / sponsor ID
- ARGOS-SC01 / ARGOS-SC01
- Conditions
- Glaucoma, Open Angle Glaucoma
- Keywords
- Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Implandata Ophthalmic Products GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single arm, multicenter
| Arm | Type | Receives |
|---|---|---|
| ARGOS-SC Sensor | Experimental | Device: ARGOS-SC suprachoroidal pressure sensorIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- Contraindications for a non-penetrating glaucoma surgery
- Myopia (> -6 dpt) or hypermetropia (> +4 dpt)
- Axis length < 22 mm or > 26 mm
- Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- Acute retinal detachment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGOS-SC suprachoroidal pressure sensorThe sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery. | Device | ARGOS-SC Sensor |
Primary outcome
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Time frame: 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.
7 secondary outcomes
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Time frame: 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)
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
Performance: Percentage of Measurements Within +/- 5 mmHg
Time frame: Day 1 to Day 360 (V02 to V09)
Performance: Device Malfunctions
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
Usability: Implantation Procedure
Time frame: Day 1 (V01 [Implantation])
Usability: User Acceptance at the Investigational Site
Time frame: Day 1 to Day 360 (V02 to V09)
Usability: User Acceptance at Home
Time frame: Day 1 to Day 360 (V02 to V09)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36202141Szurman 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.
- Derived from this study: PubMed 34772665Szurman 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Szurman, Prof. principal investigator
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARGOS-SC suprachoroidal pressure sensor in people with Glaucoma and Open Angle Glaucoma, run by Implandata Ophthalmic Products GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance: Level of Agreement Between GAT and the ARGOS-SC System (time frame: Day 1 to Day 360 (V02 to V09)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.