An interventional study of ARGOS-SC suprachoroidal pressure sensor in Glaucoma and Open Angle Glaucoma, sponsored by Implandata Ophthalmic Products GmbH. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Implandata Ophthalmic Products GmbH · Not applicable, Interventional, and Diagnostic
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.
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).
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 24 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Contraindications for a non-penetrating glaucoma surgery
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
The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
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.
Time frame: Day 1 to Day 360 (V02 to V09)
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
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)
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Time frame: 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.
Time frame: Day 1 to Day 360 (V02 to V09)
Performance: Device Malfunctions
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 360 (V02 to V09)
Recruitment from November 2018 to January 2020 in medical clinics.
| Milestone | ARGOS-SC Sensor |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Due to an sae that was not related to the medical device or medical procedure. | 1 |
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
| mmHg | ARGOS-SC Sensor |
|---|---|
| Overall Level of Agreement | 0.8 (-5.1 to 6.7) |
| Level of Agreement 3-month post-operatively until the end of the follow-up | -0.2 (-4.6 to 4.2) |
Number of patients experiencing a device-related SAE (SADE).
| participants | ARGOS-SC Sensor |
|---|---|
| Safety: Number of Patients Experiencing a Device-related SAE (SADE) | 0 |
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
| A(D)Es | ARGOS-SC Sensor |
|---|---|
| Overall number of AEs/ADEs affecting the study eye, of which | 54 |
| AEs related to medical procedure and/or | 44 |
| AEs related to medical device and/or | 16 |
| AEs related to other | 7 |
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.
| percentage of measurements | ARGOS-SC Sensor | ARGOS-SC Sensor After 3 Month Postoperative |
|---|---|---|
| Performance: Percentage of Measurements Within +/- 5 mmHg | 91 | 98 |
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
| DDs | ARGOS-SC Sensor |
|---|---|
| Reader device (external handheld device) | 14 |
| ARGOS-SC sensor (recalibration of the reader device for compensation, one (1) discontinued use) | 4 |
| Both reader device and ARGOS-SC sensor | 5 |
| Other | 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). Overall Number of Participant Analyzed represents the 7 surgeons who provided feedback via a structured questionnaire. The score 7 represents a greater user acceptance.
| score on a scale | ARGOS-SC Sensor |
|---|---|
| Usability: Implantation Procedure | 6.6 ± 2.1 |
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.
| score on a scale | ARGOS-SC Sensor |
|---|---|
| Usability: User Acceptance at the Investigational Site | 5.5 ± 3.1 |
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.
| score on a scale | ARGOS-SC Sensor |
|---|---|
| Usability: User Acceptance at Home | 5.7 ± 3.2 |
Collected over Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARGOS-SC Sensor | 0/24 (0%) | 7/24 (29.2%) | 24/24 (100%) |
| Event | ARGOS-SC Sensor |
|---|---|
| SyncopeGeneral disorders | 2/24 |
| acute dyspnoeRespiratory, thoracic and mediastinal disorders | 1/24 |
| Cerebral ischemia, left, suspectedNervous system disorders | 1/24 |
| chronic sleep apnoeGeneral disorders | 1/24 |
| Hallux Valux SurgerySurgical and medical procedures | 1/24 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/24 |
| Spinal FractureInjury, poisoning and procedural complications | 1/24 |
| Stomach acheGastrointestinal disorders | 1/24 |
| Syncope, retrograd amnesie and fracture of vertebraeGeneral disorders | 1/24 |
| intestinak surgery (removal of carcinoma)Surgical and medical procedures | 1/24 |
| Event | ARGOS-SC Sensor |
|---|---|
| HyphemaEye disorders | 9/24 |
| HyposphagmaEye disorders | 3/24 |
| Secondary CataractEye disorders | 3/24 |
| Touch sensitivity of the eyeEye disorders | 3/24 |
| Intraocular pressure increased non-study eyeEye disorders | 3/24 |
| surgical intervention non-study eyeEye disorders | 3/24 |
| Conjunctival Wound leakEye disorders | 2/24 |
| Endothelium, ErythrocytesEye disorders | 2/24 |
| Eye PainEye disorders | 2/24 |
| Reduction of retinal nerve fibre thicknessEye disorders | 2/24 |
| Age, Categorical(Participants) | ARGOS-SC Sensor |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 15 |
| Age, Continuous(years) | ARGOS-SC Sensor |
|---|---|
| Mean | 65.2 ± 10.2 |
| Sex: Female, Male(Participants) | ARGOS-SC Sensor |
|---|---|
| Female | 12 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | ARGOS-SC Sensor |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | ARGOS-SC Sensor |
|---|---|
| Switzerland | 4 |
| Germany | 20 |
| Type of Glaucoma(Participants) | ARGOS-SC Sensor |
|---|---|
| Primary open-angle glaucoma (POAG) | 17 |
| Ocular hypertension (OHT)/Glaucoma suspect | 2 |
| Pseudoexfoliative (PEX) glauoma | 2 |
| Other | 3 |
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Implandata Ophthalmic Products GmbH