- Clareon family of intraocular lenses (IOLs) delivers
excellent vision, exceptional clarity and predictable refractive
outcomes in a glistening-free§ IOL material1-3
- Long-lasting clarity of the Clareon IOL and extensive
real-world experience with excellent outcomes demonstrated in 30
peer-reviewed studies4-6
- Global rollout of Clareon portfolio has started; U.S. to
launch Clareon Monofocal, Clareon PanOptix and Clareon Vivity IOLs
in March with additional countries planned throughout 2022
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, today announced the launch of
the Clareon® family of intraocular lenses (IOLs) in the U.S.
Utilizing Alcon’s most advanced IOL material, Clareon can deliver
consistent visual outcomes and exceptional clarity that lasts.°,1-7
The Clareon clarity is born out of a glistening-free§ IOL material
that has among the lowest levels of haze and subsurface
nanoglistenings (SSNGs) compared to leading competitor
IOLs.†,*,1-3
“We are proud to offer our latest IOL technology in the U.S. and
other countries across the globe. At Alcon, we are consistently
pushing the boundaries to deliver transformational innovation to
cataract surgeons and their patients,” said Ian Bell, President,
Global Business & Innovation, Alcon. “Clareon is the result of
robust R&D efforts at every level—inventive material science,
advanced manufacturing techniques and novel delivery systems—to
deliver exceptional, long-lasting clarity.”
The Clareon portfolio leverages many of the same design
characteristics and optics as Alcon’s leading IOLs to help deliver
the outcomes surgeons expect.8,9 Clareon offers sharp, crisp vision
with a proprietary edge designed to help reduce glare and posterior
capsular opacification.7 The lens’ unique and proven STABLEFORCE®
Haptics provide superior axial and rotational stability.*,β,8-14
Clareon has been extensively researched, with inclusion in 30
published studies worldwide. Clareon Monofocal and Clareon Toric
IOLs have already been implanted in more than one million eyes
across more than 70 countries.15
Clareon IOLs are inserted using the next-generation, reusable
Clareon Monarch® IV Delivery System, which provides precise and
controlled implantation and that was designed specifically for the
new Clareon material.15,16 Clareon Monofocal is also available in
the next-generation automated, single-use delivery system,
AutonoMe™.
“As one of the investigators for the Clareon pivotal trial, I
was immediately impressed with the clarity of the new IOL material,
delivery system and the consistent refractive outcomes,” said Dr.
Samuel H. Lee, MD, Ophthalmologist, Sacramento, CA.** “Today, the
clarity of Clareon persists four years later in my trial patients,
with the optic performance that I expect from Alcon IOLs, as well
as continued high patient satisfaction.”
Clareon Monofocal, Clareon PanOptix®, Clareon PanOptix Toric,
Clareon Vivity® and Clareon Vivity Toric IOLs are now available in
the U.S. Clareon PanOptix offers patients the possibility of 20/20
vision at distance (far), intermediate (at arm’s length) and near
(up close), with continuous vision of 20/25 or better.¥,14,17
Clareon Vivity is a non-diffractive extended depth of focus lens
with wavefront-shaping X-WAVE™ technology, delivering
monofocal-quality distance with excellent intermediate and
functional near vision and with a monofocal visual disturbance
profile.13,18
Clareon Toric will be available in the U.S. later this year.
Alcon will be rolling out the Clareon family of IOLs in
international markets throughout 2022 and 2023.
There are more than 28 million cataract surgeries performed each
year in the world. With the aging population and increased life
expectancies, these surgeries are expected to increase 3-4% per
year for the next 30 years, leading to an estimated 60 million
global cataract surgeries annually by 2045.19
About Cataracts
A cataract is a cloudy area in the natural lens of the eye that
affects vision. As a cataract develops, the eye's lens gradually
becomes hard and cloudy, allowing less light to pass through, which
makes it more difficult to see. The vast majority of cataracts
result from normal aging, but radiation exposure, taking steroids,
diabetes and eye trauma can accelerate their development. Cataracts
are the most common age-related eye condition and the leading cause
of preventable blindness.20 Cataracts are treated by removing the
eye's cloudy natural lens and surgically replacing it with an IOL.
More than 92% of cataract surgeries are considered successful, and
patients typically can return to their normal routines within 24
hours.21
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 24,000 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.
*Compared to TECNIS, TECNIS OptiBlue,
Eternity W-60, Vivinex XY1 and EnVista. Trademarks are the property
of their respective owners **Dr. Lee is a paid Alcon consultant §
“Glistening-free” is defined as Miyata grade 0 or <25mv/mm2
°Long-term defined as over 3 years (n=138), and over 9 years, n=20
respectively †Based on in vitro examinations of glistenings, SSNG
and surface haze ‡Clareon® and AcrySof® share the same -0.2µm
aspheric design resulting in improved depth of focus ¥ Based on the
binocular defocus curve at 0D, -1.5D, and -2.5D (n=129). Snellen VA
was converted from logMAR VA. A Snellen notation of 20/20-2 or
better indicates a logMAR VA of 0.04 or better, which means 3 or
more of the 5 ETDRS chart letters in the line were identified
correctly β Both AcrySof and Clareon are designed with STABLEFORCE
Haptics
References
- 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.
- 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.
- Clareon® IOL Directions for Use.
- 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/.
- 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.
- ILJ466-P003 CSR, Sections 1-11 (v0.36) V-RIM-0049247.
- 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.
- 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.
- TDOC-0054028 (2017) - Clareon SY60WF Axial Displacement Study
at Varied Compressions.
- 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.
- 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.
- 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.
- Clareon® Vivity Directions for Use.
- Clareon® PanOptix Directions for Use.
- Alcon Data on File, 2021.
- CLAREON MONARCH IV IOL Delivery System – Proposed Instructions
for Use – Final
- 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.
- Bala, Chandra, et al. Multi-country clinical outcomes of a new
nondiffractive presbyopia-correcting intraocular lens. Journal of
Cataract and Refractive Surgery Now in Print DOI:
10.1097/j.jcrs.0000000000000712.
- Lindstrom, Richard L. (2021). Future of cataract surgery seems
promising. Healio.
- Flaxman, Seth R., et al. (2017). Global causes of blindness and
distance vision impairment 1990-2020: a systematic review and
meta-analysis
- National Institute for Health and Care Excellence, Cataracts in
Adults: Management. Accessed September 2020.
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