Alcon’s Clareon hydrophobic acrylic IOL material has been applied to its leading trifocal intraocular lens design. Melbourne’s Dr Uday Bhatt has had early access with the lens and discusses his initial impressions.
When the R&D experts at Alcon developed the company’s most advanced* intraocular lens (IOL) material to date, Clareon, Melbourne ophthalmologist Dr Uday Bhatt found himself in the first cache of surgeons globally to implant these IOLs. The intention was to assess how the material, in a monofocal design at the time, would perform over a three-year period.
“I was among approximately 12 surgeons in the world approached for the trial, and I contributed about 40 patients out of the 215 enrolled patients (424 eyes) across 19 multinational sites,” he says. “In fact, with a significant number of patients ready to go, I was the first in the world to implant a Clareon IOL at Vision Eye Institute (VEI), Footscray.”
This wasn’t the first time Bhatt was an early adopter of IOL technology. He was also the first to use Alcon’s AcrySof PanOptix trifocal in Australia and has implanted many AcrySof IQ Vivity extended depth of focus IOLs, among the highest in the world to date. In addition, he has been an investigator in several ground-breaking research projects investigating the latest IOLs and glaucoma therapies.
When using the first Clareon IOL – made from a hydrophobic acrylic with increased water content compared to AcrySof – Bhatt was immediately impressed with the clarity of the new material. The study he’s referring to also involved Dr Tim Roberts, affiliated with the University of Sydney and VEI, and results were published in February 2023. At three years, 100% of eyes implanted with the Clareon IOL presented with Grade 0 glistenings; and 92.9% of eyes (394/424) had either no posterior capsular opacification (PCO) or clinically non-significant PCO. Visual outcomes were excellent and stable over the three-year study period.1
Today, the clarity of Clareon persists several years later in his trial patients, with the optical performance he has come to expect from around two decades of implanting Alcon IOLs.
Clareon first became available to Australian ophthalmologists as a monofocal in 2018, followed by the toric version in 2020. Alcon’s PanOptix is the next IOL to be rolled out widely as part of the Clareon IOL family. It became available in Australia in June 2023, with Bhatt gaining early access to implant the IOL in a number of patients in Melbourne. Clareon PanOptix Toric will also be part of the launch.
As Bhatt explains, one of Alcon’s key motivations behind Clareon, on the basis of listening to surgeons, was to build on Alcon’s AcrySof platform which has been implanted in well over 125 million eyes globally.2
Specifically, Clareon has sought to further improve optical clarity, an important parameter in the quality assessment of IOLs. The material clarity is born out of a glistening-free material (defined as Miyata grade 0 or <25mv/mm2) that Alcon says has among the lowest levels of haze and subsurface nanoglistenings (SSNGs) compared to leading competitor IOLs.3-7†
With the Clareon material now applied to the PanOptix design, Bhatt says he is now able to deliver even greater outcomes for his patients seeking spectacle independence with a trifocal IOL.
“Seeing how Clareon has performed in monofocal and toric versions of IOLs, we can see the material has withstood the test of time. It’s an excellent material, particularly in terms of maintaining optical clarity,” he says.
Bhatt says having a glistening-free material is arguably more important on a multifocal lens like PanOptix. These fluid-filled microvacuoles might add to scattering of light resulting in dysphotopsia, decreased contrast sensitivity, and other photic phenomena that interfere with vision and are associated with diffractive multifocal IOLs. Coupled with known visual disturbances that can occur in low light with a diffractive lens design, this could become more problematic on a trifocal IOL.
“So, for that reason, it’s very important this platform is extremely robust. There’s no doubt the Clareon platform has been tested properly and I’m looking forward to Alcon rolling out this new lens material across its portfolio. They had a good lens (with AcrySof), and now we have an even better one with Clareon.”
A key part of the design is a proprietary edge to help reduce glare and posterior capsular opacification.8 The lens’ STABLEFORCE Haptics also provide superior axial and rotational stability.8-14 In addition, Clareon has been extensively researched, with inclusion in 30 published studies worldwide, while Clareon Monofocal and Clareon Toric IOLs have already been implanted in more than one million eyes across more than 70 countries.15
The latest Clareon PanOptix lens is designed to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity with a reduced need for glasses, compared to a monofocal IOL.
According to Alcon, Clareon PanOptix has been demonstrated to achieve:
• 6/6 visual acuity at distance, intermediate and near16
• A more natural intermediate focal point at 60 cm vs 80 cm17-21
• 96% of patients achieve spectacle independence22,24
• 99% of PanOptix patients would have the same lens implanted again16
Bhatt’s own one-week post-operative data for 12 patients that had Clareon PanOptix shows all patients except one have achieved 6/6 or better uncorrected distant visual acuity (UCDVA) and N6 or better uncorrected near visual acuity (UCNVA). The one patient that has not achieved this has some post-op inflammation and corneal oedema due to high intraocular pressure post-op and is improving slowly.
Clareon PanOptix Toric is also available for astigmatic patients, continuing the Alcon legacy of optimised rotational stability.8-14
In trials, 95% of Clareon IOLs had an absolute rotation of ≤5°24,25 on day one of surgery, and after six months there was a 2° mean absolute rotation of the lens.24
“It’s still quite early, but my early post-operative results are looking fantastic in terms of visual outcomes with Clareon PanOptix,” Bhatt says. “We will need to follow them up for a bit longer, and soon I would have implanted the Clareon PanOptix in another 15 to 17 patients, so that will be a reasonable number to begin understanding its performance.”
For Bhatt, the real advance with the Clareon portfolio is that it leverages many of the same design characteristics and optics that he appreciates from Alcon to help deliver the consistent outcomes surgeons expect.
“The design of Alcon lenses are very well tested, so I think it’s important that the shape, the design and other elements like the haptics to facilitate accurate centration within the capsular bag are maintained. The legacy is there, and Alcon has built on this with an improved material,” he says.
“Clareon will remain my go-to family of IOLs. Generally, when you have used these lenses in trial settings you tend to know a lot more about them. And if you’re happy with the outcomes in various testing conditions, then you can be confident about their performance in day-to-day lives.”
New delivery system
Clareon Monofocal and Toric have been available on the AutonoMe delivery system, described as the first and only automated, disposable, pre-loaded IOL injector. This is Alcon’s latest generation delivery system.
Clareon PanOptix are inserted using the reusable Clareon Monarch IV Delivery System. This manual IOL injector has been designed specifically for the Clareon material.
Some key features of the delivery system include26:
• Enlarged thread weight and twist knob for precise speed and control
• An improved thread design to reduce the number of rotations compared to Monarch III
• A precisely engineered plunger tip that uniquely grips the Clareon IOL for consistent planar deliveries
• Balanced weight to accommodate any surgeon technique
“This new lens loading system is much improved and works seamlessly with this lens, in my experience,” says Bhatt. “It holds the IOL much better and inserts it nicely into the eye, and maintains its position while delivering. It also features an enlarged thread, which means you can inject the IOL faster into the eye, if you wish to.”
* Based on Alcon’s range of IOLs
† Over 3 years (n=138), and over 9 years (n=20), respectively
1. Nuijts R, Bhatt U, Nanavaty MA, Roberts TV, Peterson R, Teus MA. Three-Year Multinational Clinical Study on an Aspheric Hydrophobic Acrylic Intraocular Lens. J Cataract Refract Surg. 2023 Feb 22. doi: 10.1097/j.jcrs.0000000000001173. Epub ahead of print. PMID: 36848238.
2. Alcon Announces Launch of AcrySof IQ Vivity, the First and Only Non-Diffractive Extended Depth of Focus Intraocular Lens in the U.S. https://www.alcon.com/media-release/alcon-announces-launch-acrysof-iq-vivity-first-and-only-non-diffractive-extended.
3. Stanojcic N et al. Visual and refractive outcomes and glistenings after implantation of 2 hydrophobic acrylic aspheric monofocal IOLs. J Cataract Refract Surg 2020;46:986-994.
4. Oshika T et al. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg 2020;46:682-687.
5. Maxwell A et al. 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. Clinical Ophthalmology 2018:12;2031-2037.
6. 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.
7. Clareon® IOL Directions for Use.
8. 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.
9. 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.
10. TDOC-0054028 (2017) – Clareon SY60WF Axial Displacement Study at Varied Compressions.
11. Kramer BA, Hardten DR, Berdahl JP. Rotation Characteristics of Three Toric Monofocal Intraocular Lenses. Clin Ophthalmol. 2020 Dec 16;14:4379-4384. doi: 10.2147/OPTH.S285818. PMID: 33364742; PMCID: PMC7751684.
12. 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.
13. Oshika T, Fujita Y, Hirota A, Inamura M, Inoue Y, Miyata K, Miyoshi T, Nakano S, Nishimura T, Sugita T. Comparison of incidence of repositioning surgery to correct misalignment with three toric intraocular lenses. Eur J Ophthalmol. 2020 Jul;30(4):680-684. doi: 10.1177/1120672119834469. Epub 2019 Mar 6. PMID: 30841757.
14. Clareon® Vivity Directions for Use.
15. Alcon Strengthens Leadership in IOL Innovation with Launch of Clareon Portfolio in the U.S. https://www.alcon.com/media-release/alcon-strengthens-leadership-iol-innovation-launch-clareon-portfolio-us.
16. Clareon® PanOptix® IOL Directions for Use.
17. Kohnen T. First implantation of a diffractive quadrafocal (trifocal) intraocular lens. J Cataract Refract Surg. 2015;41(10):2330–2332.
18. Charness N et al. Monitor viewing distance for younger and older workers. Proceedings of theHumanFactorsandErgonomicsSocietyAnnualMeeting.2008;52(19):1614–1617.
20. PlagenhoefSetal.Anatomical data for analyzing human motion. Research Quarterly for Exercise and Sport. 1983;54:169–178.
21. What is the average male height? Average Height. https://www.averageheight.co/average-male-height. Accessed November 11, 2022.
22. Böhm M et al. 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.
23. Kohnen T et al. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. Am J Ophthalmol. 2017;184:52–62.
24. Clareon Toric IOL Directions for Use.
25. Alcon Data on File, 2019. [TDOC-0055470].
26. Clareon® Monarch® IV Directions for Use.