Visual Performance and Refractive Stability of Clareon® Monofocal Intraocular Lens Implanted with an Automated Delivery System

Edward Tran,1,2 Nirmit Shah,2,3 Sandra Caballero Ortiz,2 Angela Kyveris,2 Graham Berg,2 Toby Chan2,4 1Schulich School of Medicine, University of Western Ontario, London, ON, Canada; 2Ocular Health Centre, Kitchener, ON, Canada; 3Melbourne Medical School, University of Melbourne, VIC, Australia; 4Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, CanadaCorrespondence: Edward Tran, Ocular Health Centre, 31 Kingsbury Dr Unit #501, Kitchener, ON, N2A 0K5, Canada, Email [email protected]: To evaluate the visual performance, refractive stability, and glistening-free clarity of the Clareon® monofocal intraocular lens (IOL) implanted using the AutonoMe® automated delivery system in a real-world North American setting.Patients and Methods: A prospective, single-arm study was conducted at a single Canadian site involving 46 patients, or 85 eyes, undergoing cataract surgery with Clareon® IOL implantation. Eligible participants were ≥ 22 years old with best-corrected distance visual acuity (BCDVA) of 0.3 logMAR or worse, targeted for emmetropia, and had < 1.0 D of preoperative astigmatism. Exclusion criteria included retinal disease, glaucoma, amblyopia, corneal pathology, and prior intraocular or corneal surgery. Manifest refraction, uncorrected (UDVA), best-corrected (BCDVA), and low-contrast visual acuity (LCVA) were assessed at 1, 3, and 12 months postoperatively. Glistenings were graded using the Miyata scale at 3 and 12 months.Results: No statistically significant changes were observed in manifest refraction, UDVA, or BCDVA between 1 and 3 months (p > 0.05). At 3 months, the mean spherical equivalent was +0.09 D, with low residual astigmatism (– 0.33 D). Mean logMAR UDVA and BCDVA were 0.13 and 0.02, respectively. LCVA was 0.04 logMAR. No glistenings were observed at either 3 or 12 months in any patient. Refractive and visual outcomes remained stable over time, with no device-related complications reported.Conclusion: The Clareon® IOL demonstrated excellent refractive accuracy, stable visual performance, and sustained optical clarity with no glistenings up to one year postoperatively. Its compatibility with the AutonoMe® delivery system supports its utility as a reliable option for cataract surgery.Keywords: cataract surgery, Clareon, monofocal intraocular lens, automated delivery system, surgical outcomes