As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
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.
Study Type
OBSERVATIONAL
Enrollment
750
Universitatsklinik fur Augenheilkunde Inselspital
Bern, Switzerland
RECRUITINGQoL
quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18
Time frame: 2 years after surgery
ease of use
the usability of the device will be defined by use of a surgeon questionnaire.
Time frame: 1 day
Number of participants with treatment-related incidents
collection of incidences (nature (ocular or non-ocular), number and severity) throughout the study
Time frame: up to 2 years after surgery (study completion)
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