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

Implandata Ophthalmic Products

Status: Completed

Conditions: Open Angle Glaucoma; Glaucoma

Treatments: Device: ARGOS-SC suprachoroidal pressure sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04773106

ARGOS-SC01_Follow-up

CIV-19-11-030784 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.

Exclusion criteria

• N/A

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

ARGOS-SC Sensor

Other group

Description:

The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.

Treatment:

Device: ARGOS-SC suprachoroidal pressure sensor