If clinical trials could be simulated using software and physical design parameters, companies could speed product development and would have more confidence in initiating such trials on actual products toward U.S. Food and Drug Administration (FDA) or other international regulatory approval processes. Now, such a simulation technique is a reality. Advanced Medical Optics (AMO; Santa Ana, CA) successfully used ZEMAX optical software (www.zemax.com) and postoperative ocular parameters to perform a clinical-trial simulation for intraocular lenses (IOLs) that was consistent with previously published clinical performance data.
An optical ensemble analysis method was used to input several parameters of the eye into ZEMAX software, including corneal power and asphericity; IOL defocus, decentration, and tilt; and pupil diameter. Vision performance for the 100 simulated patients was then tested when IOLs with particular design parameters were applied to the unique eye parameters of the “patients.” If additional optical parameters are added, the simulation could eventually be able to distinguish potential IOL irregularities that could arise from manufacturing problems, or show how IOL performance is affected as a patient’s eye changes due to surgical mistakes or normal healing processes. Contact Huawei Zhao at huawei.zhao@amo-inc.com.