Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-18-13-023284 | Other Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)
This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.
From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.
Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.
The sensor was always implanted in one eye only which will be the study eye.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm longterm follow-up ARGOS-IO Sensor Pressure System | Other | The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGOS-IO Sensor Pressure System | Device | The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) | Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time. | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
| Performance: Level of Agreement Between GAT and the ARGOS-IO System | Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method. | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
| Performance: Device Malfunctions | Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs) | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Compliance in IOP Self-monitoring (Daily Self-measurements) | The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening). | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hagen Thieme, Prof. | Universitätsaugenklinik Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Augenheilkunde, Uniklinik RWTH Aachen | Aachen | 52074 | Germany | |||
| Universitäts-Augenklinik Bochum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39510809 | Derived | Mansouri K, Rao HL, Weinreb RN. Nyctohemeral effects of topical beta-adrenoceptor blocking agents measured with an intraocular telemetry sensor. Br J Ophthalmol. 2025 Apr 22;109(5):582-586. doi: 10.1136/bjo-2023-324760. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment from August 2018 to May 2019 in medical clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ARGOS-IO System | ARGOS-IO Pressure sensor previously implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in the ARGOS-01 and ARGOS-02 studies. ARGOS-IO system: An active implantable intraocular pressure sensor to be implanted in the ciliary sulcus of the human eye, in combination with cataract surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2018 | Mar 18, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day) |
The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening). |
| Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
| Bochum |
| 44892 |
| Germany |
| Universitätsaugenklinik Magdeburg | Magdeburg | 39120 | Germany |
| Universitäts-Augenklinik Tübingen | Tübingen | 72076 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ARGOS-IO System | In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months. |
| 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 |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) | Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time. | Posted | Count of Participants | Participants | No | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Performance: Level of Agreement Between GAT and the ARGOS-IO System | Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method. | All available pairs of GAT and the ARGOS-IO System IOP measurements. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) | IOP measurement pairs | IOP measurement pairs |
|
| |||||||||||||||||||||||||||||||
| Primary | Performance: Device Malfunctions | Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs) | All device deficiencies. | Posted | Number | DDs | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) | DDs | DDs |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Patient's Compliance in IOP Self-monitoring (Daily Self-measurements) | The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening). | All available ARGOS-IO measurements. Of the 16 patients, 3 patients were not included in the summarizing analysis for reasons related to early withdrawal from the study and dementia, hence the 13 participants analyzed. | Posted | Mean | Standard Deviation | percentage of daily self-measurements | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day) | The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening). | All available ARGOS-IO measurements. Of the 16 patients, 3 patients were not included in the summarizing analysis for reasons related to early withdrawal from the study and dementia, hence the 13 participants analyzed. | Posted | Mean | Standard Deviation | number of self-measurement sequences/day | Baseline visit to Day 1080 (V01 [Baseline visit] to V07) |
|
|
Evaluation over 36 months' follow-up period.
SAE Definition
That meets any of the following criteria of a serious adverse event:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARGOS-IO System | A total of 16 patients from the ARGOS-01 and ARGOS-02 studies were enrolled in this open-label, multicenter study for clinical follow-up. Throughout the 36 months' clinical follow-up, the patients returned for 8 follow-up visits (V01-V07) consisting of comprehensive ophthalmic examinations as well as IOP measurements with the ARGOS-IO system and GAT. | 0 | 16 | 10 | 16 | 8 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pelvic fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Increased intraocular pressure | Investigations | Systematic Assessment |
| ||
| Increased intraocular pressure -non-study eye- | Investigations | Systematic Assessment |
| ||
| Arthralgia -shoulder- | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Plasma cell myeloma in remission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dementia | Nervous system disorders | Systematic Assessment |
| ||
| Loosening of shoulder joint prothesis | Product Issues | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hip arthroplasty | Surgical and medical procedures | Systematic Assessment |
| ||
| Joint arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
| ||
| Visual acuity reduced -non-study eye- | Eye disorders | Systematic Assessment |
| ||
| Reduced general health | General disorders | Systematic Assessment |
| ||
| Intraocular pressure increased | Investigations | Systematic Assessment |
| ||
| Anterior chamber inflammation | Eye disorders | Systematic Assessment |
| ||
| Arthralgia -knee- | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blepharitis | Eye disorders | Systematic Assessment |
| ||
| Cardiovascular decompensation | Cardiac disorders | Systematic Assessment |
| ||
| Cataract surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Conjunctival irritation b/o allergy to preservatives | Eye disorders | Systematic Assessment |
| ||
| Conjunctivitis allergic OU | Eye disorders | Systematic Assessment |
| ||
| Conjunctivitis OU | Infections and infestations | Systematic Assessment |
| ||
| Contusion -wrist- | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Corneal dystrophy OU | Eye disorders | Systematic Assessment |
| ||
| Corneal endothelial cell loss | Eye disorders | Systematic Assessment |
| ||
| Dermatitis allergic -periocular skin- | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Epiretinal membrane | Eye disorders | Systematic Assessment |
| ||
| Eye heamatoma | Eye disorders | Systematic Assessment |
| ||
| Fatigue (b/o suspected side effects of medications) | General disorders | Systematic Assessment |
| ||
| Gait disturbance | General disorders | Systematic Assessment |
| ||
| Glaucoma surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Herpes Keratitis OU | Infections and infestations | Systematic Assessment |
| ||
| Increased intraocular pressure -non-study eye- | Eye disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lentodonesis -non-study eye- | Eye disorders | Systematic Assessment |
| ||
| Muscle rupture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Oedema peripheral -leg- | General disorders | Systematic Assessment |
| ||
| Optic disk haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Phimosis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Posterior capsule opacification | Eye disorders | Systematic Assessment |
| ||
| Posterior capsule opacification -non-study eye- | Eye disorders | Systematic Assessment |
| ||
| Procedural dizziness | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Retinal tear | Eye disorders | Systematic Assessment |
| ||
| Skin lesion -wrists and forearms- | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Visual acuity reduced OU | Eye disorders | Systematic Assessment |
| ||
| Worsening of allergic reaction to eye drops | Immune system disorders | Systematic Assessment |
| ||
| Worsening of glaucoma | Eye disorders | Systematic Assessment |
| ||
| Worsening of glaucoma OU | Eye disorders | Systematic Assessment |
| ||
| Wound dehiscence -knee- | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Implandata Ophthalmic Products | +49 (0) 511 - 2204 2580 | clinical@implandata.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2022 | Mar 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| IOP measurement pairs |
|
|
| DDs |
|
|
|
|