This standard specifies specific requirements for clinical investigations of intraocular lenses implanted in the eye to correct aphakia.
A risk analysis according to ISO 14971 will be applied. If the risk analysis identifies a clinical investigation need, the requirements of ISO 14155 will be applied along with the additional requirements given in this standard.
If a new IOL model is a modification of a parental IOL whose safety and performance have already been established through clinical research in accordance with this document, a limited additional clinical trial or no additional clinical trial may be sufficient. ISO/TR 22979 provides guidance in determining the need for clinical research.
A clinical trial will be designed to compare adverse event rates and visual acuity above defined thresholds of the IOL model with results from historical data.
Prior to any clinical investigation of a toric intraocular lens, the rotational stability of a mechanically and geometrically equivalent non-toric version of that IOL model must be demonstrated.
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