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Active, not recruitingNCT04524416STAR-GLOBALUpdated Jun 11, 2026

MINIject Global Long-Term Follow-up Study

An observational study in Open Angle Glaucoma and Ocular Hypertension, sponsored by iSTAR Medical. Active, not recruiting at 9 sites in 6 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by iSTAR Medical · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
116
Ages
18 Years to 99 Years
Sex
All
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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.

Read the 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, 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.

02

Conditions studied

  • Open Angle Glaucoma
  • Ocular Hypertension

Keywords

  • Open Angle Glaucoma
  • Intra Ocular Pressure (IOP) reduction
  • Glaucoma Drainage Device
  • Minimally Invasive Glaucoma Surgery (MIGS)
  • Supraciliary space
  • Ocular hypertension
03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 116 is above the median of 101 across 182 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

iSTAR Medical is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
116 participants (actual)
Patient registry
No

Interventions

  • DeviceMinimally invasive glaucoma surgery (MIGS)

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 5 years post-implantation

07

Study locations

9 sites
  • Clinica Oftalmologica del Caribe
    Barranquilla, Colombia
  • Center Hospotalier Universitaire Genoble Alpes
    Grenoble, 38043, France
  • Hopital de la Croix-Rousse
    Lyon, 69417, France
  • Uniklinik Köln
    Cologne, North Rhine-Westphalia 50937, Germany
  • Universitätsklinikum Mainz
    Mainz, Rhineland-Palatinate 55131, Germany
  • Klinikum der Universität München
    München, 81377, Germany
  • Maxivision Eye Hospital
    Hyderabad, Telangana 500034, India
  • Panama Eye Center
    Panama City, Panama
  • Hospital Clínico San Carlos
    Madrid, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04524416
Lead sponsor
iSTAR Medical
Responsible party
Sponsor
First posted
Aug 24, 2020
Start date
Aug 5, 2020
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 11, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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