Purpose: 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.