STAR-LIFE: a Post-market Registry on MINIject

iSTAR Medical

Status: Enrolling

Conditions: Open Angle Glaucoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05269680

STAR-LIFE (ISM11)

Details and patient eligibility

About

As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Full description

The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18+ years
• diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
• able to give consent

Exclusion criteria

• eyes with angle closure glaucoma
• eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
• patients with known intolerance or hypersensitivity to silicone
• patients unable to give consent