New Head-to-Head Data Show Clareon Monofocal IOLs and TECNIS Eyhance Monofocal IOLs Provide Similar Range of Vision

• An investigator led, non-interventional study evaluated the performance of two monofocal intraocular lenses (IOLs) in 620 eyes of 310 cataract patients in the U.S.¹
• Clareon monofocal IOL provides excellent distance vision, and intermediate vision that is non-inferior to TECNIS Eyhance^* monofocal IOL^1,2
• The full Clareon Collection also offers surgeons clinically-proven extended depth of focus and presbyopia-correcting IOL options for patients desiring extended range of vision from cataract surgery³

FORT WORTH, Texas--(BUSINESS WIRE)-- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced results from a new study presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting taking place in San Diego, CA (May 5-8). The investigator-initiated study^** led by J. Morgan Micheletti, M.D., demonstrated that Clareon^® and Eyhance^* monofocal IOLs provide similar range of vision, including distance and intermediate visual acuity.¹

“The Eyhance monofocal IOL was introduced into our practice as a next-generation 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," said Dr. Micheletti, Director of Research at Berkeley Eye Center. “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 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:¹

• 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,” said 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 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

For information on the Clareon Collection of IOLs, please visit ClareonIOL.com.

About Clareon^® IOLs and Delivery Systems

The family of Clareon^® intraocular lenses (IOLs) includes the Clareon^® Aspheric Hydrophobic Acrylic and Clareon^® Aspheric Toric IOLs, the Clareon^® PanOptix^® Trifocal Hydrophobic IOL, Clareon PanOptix^® Toric, Clareon Vivity^® Extended Vision Hydrophobic Posterior Chamber IOL and Clareon^® Vivity^® Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon^® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon^® PanOptix^® lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon^® Vivity^® lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity. All of these IOLs are intended for placement in the capsular bag. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon, informing them of possible risks and benefits associated with these IOLs. Reference the Directions for Use labelling for each IOL for a complete listing of indications, warnings and precautions.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.

*Trademarks are the property of their respective owners
**This investigator-initiated study was supported by Alcon

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.

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