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Clinical Trials in France / NCT04524416
Active, not recruiting Observational

MINIject Global Long-Term Follow-up Study

NCT04524416 · tracked via the Priya Life Science France tracker
Sponsor
iSTAR Medical
Phase
Observational
Started
2020-08-05
Last updated
2026-06-11

Condition(s) studied

Open Angle GlaucomaOcular Hypertension

Investigational drug(s) / intervention(s)

Minimally invasive glaucoma surgery (MIGS)

Minimally 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.

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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (9)

FacilityCityRegionStatus
Clinica Oftalmologica del Caribe Barranquilla Colombia
Center Hospotalier Universitaire Genoble Alpes Grenoble France
Hopital de la Croix-Rousse Lyon France
Uniklinik Köln Cologne North Rhine-Westphalia
Universitätsklinikum Mainz Mainz Rhineland-Palatinate
Klinikum der Universität München München Germany
Maxivision Eye Hospital Hyderabad Telangana
Panama Eye Center Panama City Panama
Hospital Clínico San Carlos Madrid Spain

More iSTAR Medical trials in France

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program Active, not recruiting

Other trials for the same condition

Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery Recruiting
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04524416 on ClinicalTrials.gov ↗ ← All trials in France