ASCRS 2023: New head-to-head data show monofocal IOLs provide similar range of vision

According to Alcon, the non-interventional, comparative study, aimed to evaluate visual outcomes in patients implanted with bilateral Clareon monofocal IOLs versus bilateral Eyhance monofocal/toric IOLs. (Image courtesy of Adobe Stock/Jon Bilous)

Alcon has announced results from a new study presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting taking place in San Diego, California, demonstrating that Clareon and Eyhance monofocal IOLs provide similar range of vision, including distance and intermediate visual acuity.

According to a company news release, The investigator-initiated study led by J. Morgan Micheletti, MD, highlighted the IOLs.¹

Micheletti, director of Research at Berkeley Eye Center, pointed out the Eyhance monofocal IOL was introduced into his practice as an IOL offering to slightly extend the range of vision for our patients undergoing cataract surgery.

“However, we observed that our patients' postoperative intermediate visual outcomes did not consistently demonstrate discernible improvements over other monofocal IOLs," Micheletti said in the news release. “In order to explore this further, we decided to look at real-world evidence by prospectively evaluating the vision of patients who had previously been implanted with bilateral Clareon monofocal IOLs or Eyhance IOLs. Given that our study of 310 patients (620 eyes) did not find a clinically significant difference between Clareon and Eyhance IOLs in terms of intermediate vision, this study adds to the growing body of data that raises questions about the scientific validity of the ‘monofocal plus’ terminology at this point in time.”

The compay noted in the release the non-interventional, comparative study, aimed to evaluate visual outcomes in patients implanted with bilateral Clareon monofocal IOLs versus bilateral Eyhance monofocal/toric IOLs. The study evaluated 620 eyes of 310 patients (155 Clareon and 155 Eyhance) who had undergone successful, uncomplicated cataract surgery at least three months prior and had post-operative best-corrected distance visual acuity of 20/25 or better after cataract removal. ¹

Additional study findings include:

• Best-corrected distance acuity in eyes implanted with Clareon (0.01 logMAR) was similar to best-corrected distance acuity with Eyhance (0.02 logMAR).
• Distance-corrected intermediate acuity was similar in both groups (Eyhance vs Clareon) with only a 2.5 letter mean difference.
• The binocular defocus curves were extremely similar from +1.00 D to -3.00 D further demonstrating similar range of vision for both monofocal IOLs.

“At Alcon, research is the foundation for how we improve lives, and it goes beyond R&D—we also support real-world studies after our products move to market,” Jim Di Filippo,vice president and general manager, US Surgical Franchise at Alcon. “We’re extremely proud of the innovation behind Clareon, our latest IOL material, which has now been implanted in more than three million people worldwide—and delivers on our promise of exceptional clarity with the real-world outcomes doctors and patients expect from Alcon.”

The company noted the FDA has specific standards for what constitutes an extended depth of focus (EDOF) lens, based on four criteria from the American National Standards Institute (ANSI).⁴ Eyhance monofocal IOLs and Clareon monofocal IOLs do not meet these criteria. The Clareon Vivity IOL is the only available non-diffractive IOL that has received this FDA EDOF designation—offering patients excellent distance, excellent intermediate and functional near vision, with low incidence of visual disturbances. ³

References

1. Micheletti JM, Duncan N, Hall B. Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses. Presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting; May 5-8, 2023; San Diego, CA, USA.
2. Clareon IOL Aspheric Hydrophobic Acrylic IOL with the AutonoMe Directions for Use.
3. Clareon Vivity IOL Directions for Use.
4. For Ophthalmics – Extended Depth of Focus Intraocular Lenses. American National Standard. 2018.