Alcon Launches Clareon Presbyopia Correcting IOLs in India

Alcon announced the launch of the Clareon family of IOLs in India. Clareon is designed to deliver consistent visual outcomes and exceptional clarity that lasts and is features a glistening-free IOL material that has among the lowest levels of haze and subsurface nanoglistenings (SSNGs), compared to competitor IOLs, according to Alcon. [12-18]

The Clareon platform is available in India in two PCIOL technologies:

• Clareon PanOptix, which delivers exceptional clarity and offers spectacle independence across all distances with a patient satisfaction rate of 99.2% [31-34];
• PanOptix Trifocal IOL, implanted over 2.2 million times, making it the most widely implanted trifocal IOL in the world
• Clareon Vivity with wavefront-shaping X- WAVE technology, offering clinically proven exceptionally low rate of visual disturbances and unsurpassed clarity
• Vivity IOL, designed to extend vision and simplify the presbyopia-correcting experience for surgeons and patients while delivering monofocal- like certainty [1-11]

References

1. Clareon® Vivity® IOL Directions for Use.
2. Alcon Data on File, US Patent 9968440 B2, May 15, 2018.
3. Bala C, et al. Multi-country clinical outcomes of a new nondiffractive presbyopia-correcting intraocular lens. J Cataract Refract Surg. 2022;48(2):136-143.
4. Alcon Data on File. TDOC-0055576. 23-Jul-2019
5. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019;45(10):1490-1497.
6. Alcon Data on File. A01970-REP-211731. 12 Jan 2022.
7. Alcon Data on File, TDOC-0056718. 18-Jun-2019
8. Ligabue E, et al. ACRYSOF IQ VIVITY: Natural vision at a range of distances provided by a novel optical technology. Cataract & Refractive Surgery Today. April 2020
9. Alcon Data on file. A02062-REP-043696, Optical Evaluations of Alcon Vivity®, Symfony*, Zeiss* AT LARA* AT LISA IOLs. Feb 2020
10. Lawless M. Insight news. "An IOL to change the cataract surgery paradigm?" available at "https://www.insightnews.com.au/an-iol-to-change-the-cataract-surgery-paradigm/". Accessed Date 17.07.2020.
11. Ike K. Ahmed, et al. The Vivity Extended Depth of Focus IOL: Our Clinical Experience. Cataract & Refractive Surgery Today. February 2021//
12. Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021 Apr 20;15:1647-1657. Doi: 10.2147/OPTH.S295008. PMID: 33907378; PMCID: PMC8068507.
13. Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Cañones-Zafra R, Teus MA. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019 Oct;45(10):1490-1497. Doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6. PMID: 31399323.
14. Clareon® IOL Directions for Use.
15. Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic 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/.
16. Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg. 2020 May;46(5):682-687. Doi: 10.1097/j.jcrs.0000000000000142. PMID: 32358260.
17. ILJ466-P003 CSR, Sections 1-11 (v0.36) V-RIM-0049247.
18. Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye assessment of glare or positive dysphotopsia-type photic phenomena: Comparison of a new material IOL to other monofocal IOLs. J Cataract Refract Surg. 2019 Feb;45(2):219-227. Doi: 10.1016/j.jcrs.2018.09.017. Epub 2018 Nov 22. PMID: 30471850.
19. Lane, S., Collins, S., Das, K. K., Maass, S., Thatthamla, I., Schatz, H., … & Jain, R. (2019). Evaluation of intraocular lens mechanical stability. Journal of Cataract & Refractive Surgery, 45(4), 501-506.
20. 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 2018 Mar 12. PMID: 29544960.
21. Alcon Data on File, 2021.
22. CLAREON MONARCH IV IOL Delivery System – Instructions for Use_11/2021
23. Modi Et al. Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens. 2020 Sep 28;S0161-6420(20)30677-1
24. Market Scope 2022 IOL Market Report
25. Alcon data on file, REF-18881, 2022
26. Ref: Zhu D. et al., Rate of Complete Spectacle Independence with a Trifocal Intraocular Lens: A Systematic Literature Review and Meta-Analysis, Journal of Ophthalmology and Therapy, 02/2023
27. Clareon Vivity Instructions For Use, 02/2022
28. Lindstrom, Richard L. (2021). Future of cataract surgery seems promising. Healio. https://www.healio.com/news/ophthalmology/20210126/future-of-cataract-surgery-seems-promising, accessed 5th of May 2023.
29. Flaxman, Seth R., et al. (2017). Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis
30. National Institute for Health and Care Excellence, Cataracts in Adults: Management. Accessed September 2020.
31. Böhm M, Petermann K, Hemkeppler E, Kohnen T. Defocus curves of 4 presbyopia-correcting
    IOL designs: Diffractive panfocal, diffractive trifocal, segmental refractive, and extended-depth-of-focus. J Cataract Refract Surg. 2019;45(11):1625-1636. Doi:10.1016/j.jcrs.2019.07.014
32. Kohnen T, Herzog M, Hemkeppler E, et al. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. AM J Ophthalmol. 2017;184:52-62. doi:10.1016/j.ajo.2017.09.0916
33. Clareon® PanOptix Directions for Use, 08/2021; www.ifu.alcon.com
34. Modi Et al. Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens. 2020 Sep 28;S0161-6420(20)30677-1