Status:

RECRUITING

MINIject Global Long-Term Follow-up Study

Lead Sponsor:

iSTAR Medical

Conditions:

Open Angle Glaucoma

Ocular Hypertension

Eligibility:

All Genders

18-99 years

Brief Summary

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a...

Detailed Description

The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study,...

Eligibility Criteria

Inclusion

  • Patient who received a MINIject glaucoma implant within a prior clinical study
  • Patient continues to have MINIject implanted at the point of enrolment
  • Patient must provide written informed consent to participate

Exclusion

  • Individuals under tutorship or trusteeship
  • Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Key Trial Info

Start Date :

August 5 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04524416

Start Date

August 5 2020

End Date

December 1 2025

Last Update

February 28 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Clinica Oftalmologica del Caribe

Barranquilla, Colombia

2

Center Hospotalier Universitaire Genoble Alpes

Grenoble, France, 38043

3

Hopital de la Croix-Rousse

Lyon, France, 69417

4

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany, 50937