Clinical evaluation of a new hydrophobic acrylic intraocular lens with a novel delivery system

Abstract

Purpose: To evaluate clinical outcomes of patients implanted with the Clareon® monofocal intraocular lens (IOL) with AutonoMe™, an automated disposable preloaded delivery device.Design: Retrospective review.Methods: One hundred and eight eyes of 88 patients underwent uneventful phacoemulsification cataract surgery and implantation with the Clareon IOL. The primary endpoints were best-corrected distance acuity (BCDA), uncorrected distance acuity (UCDA), and proportion of patients achieving UCDA of logarithm of Minimal Angle of Resolution (logMAR) 0.18 or better at 1 month. Secondary endpoints included refractive stability and predictability, contrast sensitivity as well as wound stretch and surgically induced astigmatism (SIA).Results: The mean BCDA and UCDA at 1 month were logMAR 0.06 ± 0.08 and 0.18 ± 0.17, respectively. 93.8% of eyes had BCDA of logMAR 0.18 or better, and all eyes had BCDA of logMAR 0.3 or better. 80.9% of eyes had UCDA of 0.18 or better, and 97.8% of eyes had UCDA of 0.3 or better. All eyes were within 0.75 D of refractive target, 90.9% were within 0.5 D, and 68.7% were within 0.25 D. The mean contrast values (logMAR) were 1.73 ± 0.18 at 3 cpd, 1.91 ± 0.24 at 6 cpd, 1.62 ± 0.25 at 12 cpd, and 1.09 ± 0.28 at 18 cpd. Mean wound stretch and centroid SIA for a 2.2 mm incision was 0.04 ± 0.05 mm and 0.10 D, respectively. There was no wound stretch for a 2.4 mm incision and centroid SIA was 0.23 D.Conclusion: The Clareon IOL provided excellent visual outcomes and good refractive predictability. The AutonoMe delivery system did not cause significant corneal wound stretch or astigmatism.