Visual Performance and Refractive Stability of Clareon^® Monofocal Intraocular Lens Implanted with an Automated...

Area of Science:

• Ophthalmology
• Biomedical Engineering

Background:

• Cataract surgery involves implanting intraocular lenses (IOLs) to restore vision.
• Assessing the long-term performance and optical clarity of new IOLs is crucial for patient outcomes.

Purpose of the Study:

• To evaluate the visual performance and refractive stability of the Clareon monofocal intraocular lens (IOL).
• To assess the glistening-free optical clarity of the Clareon IOL when implanted using the AutonoMe automated delivery system.
• To examine the real-world effectiveness of this IOL and delivery system combination in North America.

Main Methods:

• A prospective, single-arm study was conducted with 46 patients (85 eyes) undergoing cataract surgery.
• Patients received the Clareon monofocal IOL via the AutonoMe delivery system.
• Visual acuity (UDVA, BCDVA, LCVA) and refractive error were measured at 1, 3, and 12 months postoperatively.
• IOL glistening was assessed using the Miyata scale at 3 and 12 months.

Main Results:

• No statistically significant changes in manifest refraction, uncorrected (UDVA), or best-corrected distance visual acuity (BCDVA) were observed between 1 and 3 months.
• Mean spherical equivalent was +0.09 D with low residual astigmatism (-0.33 D) at 3 months.
• Mean logMAR UDVA and BCDVA were 0.13 and 0.02, respectively, with LCVA at 0.04 logMAR.
• No glistenings were observed in any patient at 3 or 12 months postoperatively.
• Refractive and visual outcomes remained stable, with no device-related complications.

Conclusions:

• The Clareon monofocal IOL demonstrated excellent refractive accuracy and stable visual performance up to one year.
• The IOL maintained sustained optical clarity with no observed glistenings.
• The Clareon IOL, used with the AutonoMe delivery system, is a reliable option for cataract surgery.