Alcon launches new IOLs in the US – Tips & Results

Alcon today announced the US launch of the Clareon family of intraocular lenses

According to a company press release, by using what it calls “advanced IOL material,” Clareon is able to deliver consistent visual results and exceptional clarity that lasts.°,1-7 The Clareon Clareon is constructed from a glitter-free§ IOL material that has the lowest haze and subsurface nanoglitters (SSNGs) of any leading competitor’s IOL.†,*,1-3

“We are proud to offer our latest IOL technology in the US and other countries around the world. At Alcon, we are consistently pushing the boundaries to bring transformative innovation to cataract surgeons and their patients,” said Ian Bell, President, Global Business & Innovation, Alcon. “Clareon is the result of robust research and development efforts at every level – inventive materials science, advanced manufacturing techniques and novel delivery systems – to deliver exceptional, long-lasting clarity.”

According to the company, its portfolio uses many of the same design features and optics as Alcon’s leading IOLs to achieve the results surgeons expect.8.9 Clareon offers a sharp, clear view with a proprietary rim that helps reduce glare and posterior capsule haze.7

The Stableforce haptics of the lens provide excellent axial and rotational stability.*,β,8-14 Clareon has been extensively researched and included in 30 published studies worldwide. Clareon Monofocal and Clareon Toric IOLs have been implanted in more than one million eyes in more than 70 countries.15

Clareon IOLs are delivered with the next-generation, reusable Clareon Monarch IV Delivery System, which allows for precise and controlled implantation and was specially developed for the new Clareon material.15:16 Clareon Monofocal is also available in the next-generation automated single-use system, AutonoMe.

“As an investigator in the pivotal Clareon study, I was immediately impressed with the clarity of the new IOL material, delivery system, and consistent refractive results,” said Samuel H. Lee, MD, ophthalmologist, Sacramento, California. “Today, four years later, the clarity of Clareon continues in my trial patients, with the optical performance I have come to expect from Alcon IOLs, and a consistently high level of patient satisfaction.”

Clareon Monofocal, Clareon PanOptix, Clareon PanOptix Toric, Clareon Vivity, and Clareon Vivity Toric IOLs are now available in the US. Clareon PanOptix offers patients the option of 20/20 distance (far), middle (at arm’s length) and near (up) vision. close), with a continuous view of 20/25 or better.¥,14,17 Clareon Vivity is a non-diffractive lens with extended depth of field and wavefront-shaping X-WAVE™ technology that delivers distance monofocal quality with excellent intermediate and functional values Near vision and with a monofocal visual impairment profile.13:18

According to a press release, the company noted that Clareon Toric will be available in the US later this year. Alcon will introduce the Clareon intraocular lens family to international markets in 2022 and 2023.

More than 28 million cataract surgeries are performed worldwide each year. With an aging population and increased life expectancy, these surgeries are expected to increase by 3-4% per year over the next 30 years, leading to an estimated 60 million annual cataract surgeries by 2045.19


references

1. Lehmann R, Maxwell A, Lübeck DM, Fong R, Walters TR, Fakadej A. Efficacy and safety of the Clareon monofocal intraocular lens: results of a 12-month single-arm clinical study in a large sample. Clin Ophthalmol. Apr 20, 2021;15:1647-1657. Doi: 10.2147/OPTH.S295008. PMID: 33907378; PMC ID: PMC8068507.
2. Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Cañones-Zafra R, Teus MA. Evaluation of the clarity properties of a new hydrophobic acrylic IOL compared to commercially available IOLs. J Cataract refractive surgery. 2019 Oct 45(10):1490-1497. Doi: 10.1016/j.jcrs.2019.05.017. Epub August 6, 2019. PMID: 31399323.
3. Clareon® IOL Instructions for Use.
4. Maxwell A, Suryakumar R. Long-term efficacy and safety of a three-part hydrophobic acrylic intraocular lens modified with hydroxyethyl methacrylate: an open-label 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037 https://pubmed.ncbi.nlm.nih.gov/30349186/.
5. Oshika T, Fujita Y, Inamura M, Miyata K. Mid- and long-term clinical evaluations of a new one-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract refractive surgery. May 2020;46(5):682-687. Doi: 10.1097/j.jcrs.00000000000000142. PMID: 32358260.
6. ILJ466-P003 CSR Sections 1-11 (v0.36) V-RIM-0049247.
7. Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye evaluation of glare or positive dysphotopsia-like photic phenomena: comparison of a new material IOL with other monofocal IOLs. J Cataract refractive surgery. 2019 Feb;45(2):219-227. Doi: 10.1016/j.jcrs.2018.09.017. Epub 2018, November 22nd. PMID: 30471850.
8. Lane, S., Collins, S., Das, KK, Maass, S., Thatthamla, I., Schatz, H., … & Jain, R. (2019). Evaluation of the mechanical stability of intraocular lenses. Journal of Cataract & Refractive Surgery, 45(4), 501-506.
9. TDOC-0054028 (2017) – Clareon SY60WF axial displacement study at different compressions.
10. Kramer BA, Hardten DR, Berdahl JP. Rotational properties of three toric monofocal intraocular lenses. Clin Ophthalmol. 16 Dec 2020;14:4379-4384. doi: 10.2147/OPTH.S285818. PMID: 33364742; PMC ID: PMC7751684.
11. Lee BS, Chang DF. Comparison of the rotational stability of two toric intraocular lenses in 1273 consecutive eyes. ophthalmology. 2018 Sep;125(9):1325-1331. doi: 10.1016/j.ophtha.2018.02.012. Epub March 12, 2018. PMID: 29544960.
12. Oshika T, Fujita Y, Hirota A, Inamura M, Inoue Y, Miyata K, Miyoshi T, Nakano S, Nishimura T, Sugita T. Eur J Ophthalmol. 2020 Jul;30(4):680-684. doi: 10.1177/1120672119834469. Epub March 6, 2019. PMID: 30841757.
13. Clareon® Vivity Instructions for Use.
14. Instructions for Use for Clareon® PanOptix.
15. Alcon Archived Data, 2021.
16. CLAREON MONARCH IV IOL Delivery System – Proposed Instructions for Use – Final
17. Modi et al. Visual and patient-reported results of a diffractive trifocal intraocular lens compared to a monofocal intraocular lens. 28 Sep 2020;S0161-6420(20)30677-1.
18. Bala, Chandra, et al. Clinical results from several countries of a new non-diffractive presbyopia-correcting intraocular lens. Journal of Cataract and Refractive Surgery now in print DOI: 10.1097/j.jcrs.0000000000000712.
19. Lindstrom, Richard L. (2021). The future of cataract surgery seems bright. Unhurt.

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