Glaucoma, Open Angle Glaucoma
Conditions
Keywords
Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC
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).
Interventions
The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
Sponsors
CRO Dr. med Kottmann GmbH & Co. KG
Implandata Ophthalmic Products GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, open-label, single arm, multicenter
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
| 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. |
Countries
Germany, Switzerland
Participant flow
Recruitment details
Recruitment from November 2018 to January 2020 in medical clinics.
Participants by arm
| Arm | Count |
|---|---|
| ARGOS-SC Sensor 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 and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | due to an SAE that was not related to the medical device or medical procedure. | 1 |
Baseline characteristics
| Characteristic | ARGOS-SC Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 65.2 years STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment Germany | 20 participants |
| Region of Enrollment Switzerland | 4 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 12 Participants |
| Type of Glaucoma Ocular hypertension (OHT)/Glaucoma suspect | 2 Participants |
| Type of Glaucoma Other | 3 Participants |
| Type of Glaucoma Primary open-angle glaucoma (POAG) | 17 Participants |
| Type of Glaucoma Pseudoexfoliative (PEX) glauoma | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 7 / 24 |
Outcome results
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.
Time frame: Day 1 to Day 360 (V02 to V09)
Population: All available GAT and ARGOS-SC measurements.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ARGOS-SC Sensor | Performance: Level of Agreement Between GAT and the ARGOS-SC System | Overall Level of Agreement | 0.8 mmHg |
| ARGOS-SC Sensor | Performance: Level of Agreement Between GAT and the ARGOS-SC System | Level of Agreement 3-month post-operatively until the end of the follow-up | -0.2 mmHg |
Secondary
Performance: Device Malfunctions
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
Population: 24 device deficiencies in 14 patients have been documented and were analyzed. The safety and well-being was not affected (or had the potential to affect) in any patient.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARGOS-SC Sensor | Performance: Device Malfunctions | Reader device (external handheld device) | 14 DDs |
| ARGOS-SC Sensor | Performance: Device Malfunctions | ARGOS-SC sensor (recalibration of the reader device for compensation, one (1) discontinued use) | 4 DDs |
| ARGOS-SC Sensor | Performance: Device Malfunctions | Both reader device and ARGOS-SC sensor | 5 DDs |
| ARGOS-SC Sensor | Performance: Device Malfunctions | Other | 1 DDs |
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 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)
Population: All available GAT\<\>ARGOS-SC comparisons.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARGOS-SC Sensor | Performance: Percentage of Measurements Within +/- 5 mmHg | 91 percentage of measurements |
| ARGOS-SC Sensor After 3 Month Postoperative | Performance: Percentage of Measurements Within +/- 5 mmHg | 98 percentage of measurements |
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.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
Population: A total of 98 AEs in 22 patients were reported in the ARGOS-SC study. In overall 54 adverse events were documented in 20 patients affecting the study eye. 11 out of 98 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 or implantation procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARGOS-SC Sensor | Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) | Overall number of AEs/ADEs affecting the study eye, of which | 54 A(D)Es |
| ARGOS-SC Sensor | Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) | AEs related to medical procedure and/or | 44 A(D)Es |
| ARGOS-SC Sensor | Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) | AEs related to medical device and/or | 16 A(D)Es |
| ARGOS-SC Sensor | Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) | AEs related to other | 7 A(D)Es |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARGOS-SC Sensor | Safety: Number of Patients Experiencing a Device-related SAE (SADE) | 0 participants |
Secondary
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])
Population: After each implantation procedure, the surgeon performing the implantation procedure was asked to provide feedback on the implantation procedure and the handling of the investigational device. A total of 7 surgeons performed the implantation procedure and provided feedback via a structured questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARGOS-SC Sensor | Usability: Implantation Procedure | 6.6 score on a scale | Standard Deviation 2.1 |
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.
Time frame: Day 1 to Day 360 (V02 to V09)
Population: Each patient was asked to provide feedback on the user acceptance of the ARGOS-SC system at home. A total of 19 patients provided feedback via a structured questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARGOS-SC Sensor | Usability: User Acceptance at Home | 5.7 score on a scale | Standard Deviation 3.2 |
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 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)
Population: The user acceptance questionnaire for physicians was collected from 12 investigators.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARGOS-SC Sensor | Usability: User Acceptance at the Investigational Site | 5.5 score on a scale | Standard Deviation 3.1 |