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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-19-11-030784 | Registry Identifier | Eudamed |
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| Name | Class |
|---|---|
| CRO Dr. med Kottmann GmbH & Co. KG | INDUSTRY |
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The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01_FU study.
The sensor was always implanted in one eye only which will be the study eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARGOS-SC Sensor | Other | The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGOS-SC suprachoroidal pressure sensor | Device | The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 360 to Day 1080 (V09 to V13) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Patients Experiencing a Device-related SAE (SADE) | Number of patients experiencing a device-related SAE (SADE) | Day 360 to Day 1080 (V09 to V13) |
| Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) |
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Inclusion Criteria:
- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szurman, Prof. | Knappschaftsklinikum Saar GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Augenklinik Bochum | Bochum | 44892 | Germany | |||
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39892748 | Result | Micheletti E, Mansouri K, Dick HB, Hoffmann EM, Mackert MJ, Weinreb RN, Szurman P; EYEMATE-SC Study Group. Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology. 2025 Jul;132(7):775-784. doi: 10.1016/j.ophtha.2025.01.021. Epub 2025 Jan 31. |
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Of the ARGOS-SC01 subjects, 22 patients consented to the ARGOS-SC01 follow-up study.
Recruitment from December 2019 to February 2021 in medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARGOS-SC Sensor | ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery. ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2021 | Mar 21, 2025 |
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|
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events. |
| Day 360 to Day 1080 (V09 to V13) |
| 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 65% agreement of the total number of comparisons between +/-5 mmHg. | Day 360 to Day 1080 (V09 to V13) |
| Performance: Device Malfunctions | The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor. | Day 360 to Day 1080 (V09 to V13) |
| 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 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance. | Day 1080 (V13) |
| 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. | Day 1080 (V13) |
| Mainz |
| 55131 |
| Germany |
| Augenklinik der LMU München | München | 80336 | Germany |
| Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach | Sulzbach | 66280 | Germany |
| Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi | Lausanne | 1006 | Switzerland |
| COMPLETED | Of the 22 patients enrolled, three patients voluntarily withdrew from the study during the follow-up and one patient deceased for unrelated reasons. |
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| NOT COMPLETED |
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All ARGOS-SC01 patients who have consented to the ARGOS-SC01 follow-up study.
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| ID | Title | Description |
|---|---|---|
| BG000 | ARGOS-SC Sensor | ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery. ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Type of Glaucoma | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All available GAT and ARGOS-SC measurements. | Posted | Mean | 95% Confidence Interval | mmHg | Day 360 to Day 1080 (V09 to V13) | measurements | measurements |
|
|
| |||||||||||||||||||||||||
| Secondary | Safety: Number of Patients Experiencing a Device-related SAE (SADE) | Number of patients experiencing a device-related SAE (SADE) | Posted | Count of Participants | Participants | No | Day 360 to Day 1080 (V09 to V13) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | A total of 50 AEs in 16 patients were reported in the ARGOS-SC follow-up study. In overall 15 adverse events were documented in 14 patients affecting the study eye. 12 out of 50 AEs in 7 patients fulfilled at least one criterion for "serious adverse event" (SAE) and were reported as such. All of these SAEs were unrelated to the medical device. | Posted | Number | A(D)Es | Day 360 to Day 1080 (V09 to V13) | Total number of AEs | Total number of AEs |
|
| |||||||||||||||||||||||||||
| Secondary | 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 65% agreement of the total number of comparisons between +/-5 mmHg. | All available GAT<>ARGOS-SC comparisons. | Posted | Number | percentage of comparisons | Day 360 to Day 1080 (V09 to V13) | comparisons | comparisons |
|
| |||||||||||||||||||||||||||
| Secondary | Performance: Device Malfunctions | The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor. | Of the 22 patients, device deficiencies (all related to the Reader device (external handheld device)) have been documented for 10 patients, hence the 10 participants analyzed. | Posted | Number | DDs | Day 360 to Day 1080 (V09 to V13) | DDs | DDs |
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| |||||||||||||||||||||||||||
| Secondary | 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 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance. | The user acceptance questionnaire for physicians was collected from 8 investigators. | Posted | Mean | Standard Deviation | score on a scale | Day 1080 (V13) |
|
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| Secondary | 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. | Each patient was asked to provide feedback on the user acceptance of the ARGOS-SC system at home. A total of 15 patients provided feedback via a structured questionnaire | Posted | Mean | Standard Deviation | score on a scale | Day 1080 (V13) |
|
|
Day 360 to Day 1080 (V09 to V13). In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that
Led to death
Led to a serious deterioration in health of a subject that:
a Resulted in life-threatening illness or injury b Resulted in permanent impairment of body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function
Led to foetal distress, foetal death or a congenital abnormality or birth defect
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARGOS-SC Sensor | ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery. ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery. | 1 | 22 | 7 | 22 | 13 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone fracture, upper arm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac stent implantation | Surgical and medical procedures | Systematic Assessment |
| ||
| Death, non-related | General disorders | Systematic Assessment |
| ||
| Gastroenterological complaints | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hospitalization b/o nose surgery (removal of polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Intestinal inflammation | Infections and infestations | Systematic Assessment |
| ||
| Intraocular pressure increased | Investigations | Systematic Assessment |
| ||
| Pain and fluid accumulation in the abdominal cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pleuritis sicca | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | Systematic Assessment |
| ||
| COVID-19 infection | Infections and infestations | Systematic Assessment |
| ||
| Increased intraocular pressure | Investigations | Systematic Assessment |
| ||
| Increased intraocular pressure -non-study eye- | Investigations | Systematic Assessment |
| ||
| Visual acuity reduced | Eye disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Implandata Ophthalmic Products GmbH | +49 (0) 511 - 2204 2580 | clinical@implandata.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2022 | Mar 21, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Pseudoexfoliative (PEX) glauoma |
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| Other |
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| Total number of AEs |
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| comparisons |
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| DDs |
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