MINIject Global Long-Term Follow-up Study

Last updated: February 26, 2025
Sponsor: iSTAR Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ocular Hypertension

Glaucoma

Open Angle Glaucoma

Treatment

Minimally invasive glaucoma surgery (MIGS)

Clinical Study ID

NCT04524416
STAR-GLOBAL (ISM09)
  • Ages 18-99
  • All Genders

Study 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 MINIject glaucoma implant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Individuals under tutorship or trusteeship

  • Patient who is unwilling to return to the study visits and undergo studyassessments, as required by clinical study protocol

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Minimally invasive glaucoma surgery (MIGS)
Phase:
Study Start date:
August 05, 2020
Estimated Completion Date:
December 31, 2025

Study 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, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Connect with a study center

  • Clinica Oftalmologica del Caribe

    Barranquilla,
    Colombia

    Active - Recruiting

  • Center Hospotalier Universitaire Genoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • Hopital de la Croix-Rousse

    Lyon, 69417
    France

    Site Not Available

  • Uniklinik Köln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitätsklinikum Mainz

    Mainz, Rheinland Pfalz 55131
    Germany

    Site Not Available

  • Klinikum der Universität München

    München, 81377
    Germany

    Active - Recruiting

  • Maxivision Eye Hospital

    Hyderabad, Telangana 500034
    India

    Active - Recruiting

  • Panama Eye Center

    Panama City,
    Panama

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

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