NCT04773106

Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Implandata Ophthalmic Products GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.

Detailed description

This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01\_FU study. The sensor was always implanted in one eye only which will be the study eye.

Conditions

• Glaucoma
• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	ARGOS-SC suprachoroidal pressure sensor	The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.

Timeline

• Start date: 2020-02-20
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2021-02-26
• Last updated: 2025-05-18
• Results posted: 2025-05-18

Locations

5 sites across 2 countries: Germany, Switzerland