STAR-LIFE: a Post-market Registry on MINIject

NCT05269680 · tracked via the Priya Life Science UK tracker

Sponsor

iSTAR Medical

Phase

Observational

Started

2022-07-20

Last updated

2026-06-16

Condition(s) studied

Open Angle Glaucoma

Investigational drug(s) / intervention(s)

Implant Miniject

Implant Miniject: each participant receives an implant Miniject and are followed during 2 years

Study summary

As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 18+ years * diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject * able to give consent Exclusion Criteria: * eyes with angle closure glaucoma * eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle * patients with known intolerance or hypersensitivity to silicone * patients unable to give consent

Primary outcome measure(s)

Unexpected incidents and/or serious reportable incidents — From enrollment up to 2 years after surgery (study completion)
Collection of incidents (nature (ocular or non-ocular), number and severity) throughout the study. The number of unexpected incidents and the number of individuals presenting at least one event will be reported.

Trial sites (15)

Facility	City	Region
Medizinische Universität Graz	Graz	Austria
Universitätsklinik für Augenheilkunde u. Optometrie	Salzburg	Austria
Universitätsklinik für Augenheilkunde und Optometrie	Vienna	Austria
Knappschaftskrankenhaus University Hospital	Bochum	Germany
International Innovative Ophtalmochirurgie GbR,	Düsseldorf	Germany
Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde	Hamburg	Germany
Augenzentrum ONE/Nordblick Augenklinik Bellevue	Kiel	Germany
Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde	Lübeck	Germany
Universitätsklinikum Ulm / Augenklinik	Ulm	Germany
Glaucoma Research Center, Swiss Visio, Montchoisi clinic	Lausanne	Switzerland
East Suffolk and North Essex NHS foundation trust	Colchester	United Kingdom
Princess Alexandra Eye Pavilion, NHS Lothian	Edinburgh	United Kingdom
Imperial College NHS Trust	London	United Kingdom
Guy's and St Thomas' NHS Foundation Trust	London	United Kingdom
Maidstone and Tunbridge Wells NHS trust	Maidstone	United Kingdom

More iSTAR Medical trials in the UK

MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract Enrolling by invitation

Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma. Active, not recruiting

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma Recruiting

Other trials for the same condition

Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery 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 NCT05269680 on ClinicalTrials.gov ↗ ← All trials in the UK