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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Implandata Ophthalmic Products GmbH
- Enrollment
- 24
- Locations
- 5
- Primary Endpoint
- Performance: Level of Agreement Between GAT and the ARGOS-SC System
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Safety: Number of Patients Experiencing a Device-related SAE (SADE)(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)(Day 0 to Day 360 (V01 [Implantation] to V09))
- Performance: Percentage of Measurements Within +/- 5 mmHg(Day 1 to Day 360 (V02 to V09))
- Performance: Device Malfunctions(Day 0 to Day 360 (V01 [Implantation] to V09))
- Usability: Implantation Procedure(Day 1 (V01 [Implantation]))
- Usability: User Acceptance at the Investigational Site(Day 1 to Day 360 (V02 to V09))
- Usability: User Acceptance at Home(Day 1 to Day 360 (V02 to V09))