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OpenTrials
Active, Not Recruiting

NCT Number: NCT04524416

MINIject Global Long-Term Follow-up Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Oftalmologica del Caribe, Barranquilla, Colombia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive glaucoma surgery (MIGS)

Device

MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study.

Primary outcomes

  1. Proportion of patients with serious device-related adverse event in study eye

    Time frame: 5 years post-implantation

    The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation.

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Acronym: STAR-GLOBAL

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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