Registry for the MINIject device in treating open angle glaucoma
STAR-LIFE: a Post-market Registry on MINIject
iSTAR Medical · NCT05269680
This study is collecting information from patients using the MINIject device to treat open angle glaucoma to see how well it works and how safe it is in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iSTAR Medical (industry) |
| Locations | 1 site (Bern) |
| Trial ID | NCT05269680 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect real-world data on the MINIject device used for treating open angle glaucoma. It focuses on three main objectives: assessing the usability of the device, gathering patient-reported outcomes, and monitoring device safety over a two-year period following surgery. The data collected will help understand the effectiveness and safety of the MINIject in everyday clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who have been diagnosed with open angle glaucoma and have received or will receive the MINIject implant.
Not a fit: Patients with angle closure glaucoma or other specific types of glaucoma, as well as those unable to provide consent, may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the MINIject device for patients with open angle glaucoma.
How similar studies have performed: Other studies on minimally invasive glaucoma surgeries have shown promising results, indicating that this approach may be effective, although this specific registry is focused on post-market data collection.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Universitatsklinik fur Augenheilkunde Inselspital — Bern, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Florence Defresne
- Email: florence.defresne@istartmed.com
- Phone: +32 10 771 676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Open Angle Glaucoma, Minimally Invasive Glaucoma Surgery, MINIject