NCT03756662

Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Implandata Ophthalmic Products GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Glaucoma
• Open Angle Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-19
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2018-11-28
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

5 sites across 2 countries: Germany, Switzerland