Prediction of spectacle refraction uncertainties with discrete IOL power steps and manufacturing tolerances according to ISO using a Monte Carlo model

Purpose: The purpose of this study was to develop a concept for predicting the effects of both discrete intraocular lens (IOL) power steps (PS) and power labelling tolerances (LT) on the uncertainty of the refractive outcome (REFU). Design: Retrospective non-randomised cross-sectional Monte Carlo simulation study. Methods: We evaluated a dataset containing 16 669 IOLMaster 700 preoperative biometric measurements. The PS and the delivery range of two modern IOLs (Bausch and Lomb enVista and Alcon SA60AT) were considered for this Monte Carlo simulation. The uncertainties from PS or LT were assumed to be normally distributed according to ±½ the IOL PS or the ISO 11979 LT. REFU was recorded and analysed for all simulations. Results: With both lenses the REFU from discrete PS ranged from 0.11 to 0.12 dpt. Due to the larger PS for low/high power lenses with the enVista/SA60AT, REFU is more dominant in initially myopic/hyperopic eyes. REFU from LT ranged from 0.18 to 0.19 dpt for both lenses. Since LT increases stepwise with IOL power, REFU is more prevalent in initially hyperopic eyes requiring high IOL power values, and for lenses with a wide delivery range towards higher powers. Conclusions: Since surgeons and patients are typically aware of the effect of discrete PS on REFU, these might be tolerated in cataract surgery. However, REFU resulting from LT is inevitable while the true measured IOL power is not reported on the package, leading to background noise in postoperative achieved refraction. © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.