ISO TR 22979 Ophthalmic Implants - Intraocular Lenses - Test Standard for Evaluation of Clinical Research Need of Intraocular Lens Design Changes

Material Testing

ISO TR 22979 Ophthalmic Implants - Intraocular Lenses - Test Standard for Evaluation of Clinical Research Need of Intraocular Lens Design Changes

ISO TR 22979 provides guidance on the application of parts 11979, 3 and 7 of the ISO 9 International series of standards for intraocular lenses (IOLs). It addresses factors to consider in a risk analysis of the significance of changes in anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also recommends data analysis and interpretation methods that can be used to determine the design and need for a clinical trial.

ISO TR 22979 Ophthalmic Implants - Intraocular Lenses - Test Standard for Evaluation of Clinical Research Need of Intraocular Lens Design Changes

This standard provides risk assessment considerations to determine the clinical research effort needed based on the level of change defined in it.

Design changes to base model IOLs are classified as level A, B, or C. Examples of design-related risks on classification, identified safety and performance risks are provided in the modifications.

  • Level A modifications of a parent model are modifications in which all questions of safety and performance can be adequately addressed without clinical investigation. The modified model is essentially equivalent to the base model(s). All risks arising from risk assessment for change are adequately addressed by available clinical evidence. The remaining risk must outweigh the benefits.
  • Level B modifications of a parental model are those that increase safety or performance risks that can be adequately addressed with a limited clinical trial of a justified number of subjects followed for a reasonable period of time.
  • Level C modifications are modifications that increase safety or performance risks and can only be addressed through a full clinical investigation as defined in ISO 11979-7 and ISO 11979-10.
     

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