STAR-LIFE: a Post-market Registry on MINIject
- Conditions
- Open Angle Glaucoma
- Registration Number
- NCT05269680
- Lead Sponsor
- iSTAR Medical
- Brief Summary
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
- Detailed Description
The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 18+ years
- diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
- able to give consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ease of use 1 day the usability of the device will be defined by use of a surgeon questionnaire.
QoL 2 years after surgery quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18
Number of participants with treatment-related incidents up to 2 years after surgery (study completion) collection of incidences (nature (ocular or non-ocular), number and severity) throughout the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitatsklinik fur Augenheilkunde Inselspital
🇨ðŸ‡Bern, Switzerland