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No serious adverse device effects were reported.
The primary endpoint was freedom from serious adverse device events (SADE) at 90 days.
We classified both events as possible intervention-related unanticipated serious adverse device effects (USADE).
No serious AEs, serious adverse device effects or unanticipated adverse device effects were observed throughout the entire study.
Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) will be reported in accordance with the Sponsor's Research Related Adverse Event Reporting Policy.
The rationale for this was patient safety, i.e., in case of a serious adverse device effect, the implant can be removed and replaced with a larger human donor cornea graft by deep lamellar keratoplasty, the current conventional treatment.
Similar(53)
Serious adverse events included device embolization with percutaneous retrieval (n = 1) and postpericardiotomy syndrome without intervention (n = 1).
Patient safety evaluation included reporting of complications, adverse events (AEs), serious adverse events (SAEs) and device deficiencies.
There were no serious adverse events and no device-related adverse events.
The primary safety end point was achieved if no serious adverse events related to the device had occurred.
Normal range: leucocyte 4000 9000/μL, CRP < 0.3 mg/dL, ESR < 10 mm/hr (male); < 15 mm/hr (female) No device-related serious adverse event or unexpected adverse event was observed in either group.
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