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MINIject Global Long-Term Follow-up Study

MINIject Global Long-Term Follow-up Study

Recruiting
18-99 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 Criteria:

  • 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

Study details
    Open Angle Glaucoma
    Ocular Hypertension

NCT04524416

iSTAR Medical

27 January 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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