New Head-to-Head Data Show Clareon Monofocal IOLs and TECNIS Eyhance Monofocal IOLs Provide Similar Range of Vision
2023年5月7日 - 4:00AM
ビジネスワイヤ(英語)
- 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 IOL1,2
- 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
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
- 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.
- Clareon IOL Aspheric Hydrophobic Acrylic IOL with the AutonoMe
Directions for Use.
- Clareon Vivity IOL Directions for Use.
- For Ophthalmics – Extended Depth of Focus Intraocular Lenses.
American National Standard. 2018.
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Investor Relations Allen
Trang + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
investor.relations@alcon.com
Media Relations Steven Smith
+ 41 589 112 111 (Geneva) + 1 817 551 8057 (Fort Worth)
globalmedia.relations@alcon.com
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