10.2.1 EDF IOL as a modification of an The EDF IOL demonstrates at least 0.5 D approved monfocal parent: greater monocular photopic depth of focus compared to the At least 100 subjects in the EDF IOL and control monofocal control IOL at 0.2 logMAR arm shall be included in a bilateral implantation visual acuity threshold. study and followed up for 6 months postoperatively. Bilateral implantation shall not The median, monocular distance-corrected be implemented until initial safety and photopic intermediate visual acuity at 66 cm performance has been confirmed is at trial 0.2 logMAR. Note: Typically, bilateral implantation of the The mean, monocular best corrected EDF IOL in 30 subjects may be adequate distance acuity for the EDF IOL is for a pilot study. statistically non-inferior to the control using a non-inferiority margin of 0.1 logMAR. 10.2.2 EDF IOL without approved monofocal parent: Annex B contains suggested detail concerning a clinical investigation. In cases where no previously approved monofocal parent exists for the EDF IOL, the 11 Labeling safety and effectiveness requirements described below shall be integrated into clinical design of The requirements of ISO 11979-4 shall apply, a monofocal IOL described in ISO 11979-7. with the following additions. A graph of the spectral transmittance 10.3 Effectiveness Requirements through the EDF IOL Dioptric power The effectiveness of the EDF IOL be A graph of the MTF through focus response evaluated. The following criteria shall be met: of the EDF IOL in the model eye compared to a monofocal and multifocal IOL. The EDF IOL demonstrates statistical Instructions for use, including power superiority over the control group on mean, constant and a statement that only validated monocular distance corrected intermediate folders/ injectors shall be used. visual acuity at 66 cm. Summary of clinical trial including defocus curves for EDF IOL and control.
10.2.1 EDF IOL as a modification of an approved monfocal parent: At least 100 subjects in the EDF IOL and control arm shall be included in a bilateral implantation study and followed up for 6 months postoperatively. Bilateral implantation shall not be implemented until initial safety and performance has been confirmed Note: Typically, bilateral implantation of the EDF IOL in 30 subjects may be adequate for a pilot study. 10.2.2 EDF IOL without approved monofocal parent: In cases where no previously approved monofocal parent exists for the EDF IOL, the safety and effectiveness requirements described below shall be integrated into clinical design of a monofocal IOL described in ISO 11979-7. 10.3 Effectiveness Requirements The effectiveness of the EDF IOL be evaluated. The following criteria shall be met: The EDF IOL demonstrates statistical superiority over the control group on mean, monocular distance corrected intermediate visual acuity at 66 cm. The EDF IOL demonstrates at least 0.5 D greater monocular photopic depth of focus compared to the monofocal control IOL at 0.2 logMAR visual acuity threshold. The median, monocular distance-corrected photopic intermediate visual acuity at 66 cm is at 0.2 logMAR. The mean, monocular best corrected distance acuity for the EDF IOL is statistically non-inferior to the control using a non-inferiority margin of 0.1 logMAR. Annex B contains suggested detail concerning a clinical investigation. 11 Labeling The requirements of ISO 11979-4 shall apply, with the following additions. A graph of the spectral transmittance through the EDF IOL Dioptric power A graph of the MTF through focus response of the EDF IOL in the model eye compared to a monofocal and multifocal IOL. Instructions for use, including power constant and a statement that only validated folders/ injectors shall be used. Summary of clinical including defocus curves for EDF IOL and control. trial trial
Draft-ANSI-Z80-35-EDF-Rev-05.docx