Alcon Releases New Study Comparing the Eyhance monofocal with the Clareon monofocal
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At a recent meeting of the American Society of Cataract and Refractive Surgery, Alcon released a study indicating that intermediate and distance vision was basically the same in both the Alcon Clareon monofocal and the Johnson and Johnson Eyhance monofocal. Dated May 7.
"ASCRS 2023 New head to head data show monofocal"
0 likes, 15 replies
maura04015 Lynda111
Posted
I read this and what I got from it was since they're saying Eyhance gives you no extra intermediate, Clareon monofocals give you just as much. 😃
RebDovid Lynda111
Posted
I've been looking for this study since I first read about it last week. Unfortunately, it hasn't yet been published and the data, research methods, etc. don't yet appear to be available on the internet. According to the story in Ophthalmology Times, the claim is that "Clareon and Eyhance monofocal IOLs provide similar range of vision, including distance and intermediate visual acuity." (Emphasis added). It will be interesting eventually to find out what the study's authors mean by "similar", how similar or different the subjects were, how statistically significant the results are, and what, if anything, to make of the fact that the study only considered subjects with a postoperative best corrected distance visual acuity of 20/25 or better.
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All that said, this new study raises an interesting question: The Clareon and Tecnis 1 IOLs generally are thought to give very similar visual acuities. Comparisons of the Tecnis 1 and Eyhance show that the Eyhance gives a (modestly) broader ranger of vision than the Tecnis 1. How, then, could multiple comparisons of the Clareon and Eyhance show very similar visual acuities? Put otherwise, if C is equal to T and E is slightly better than T, how can C be equal to E?
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It will be interesting and instructive to watch this play out.
RonAKA Lynda111
Edited
This is an interesting study, but there really is not enough data provided to see what it really means. It talks about defocus curves, but does not provide them to view. That would be the most revealing data especially if the curves included standard deviation error bars. The one part that caught my eye was they talk about comparing the outcome on a "best-corrected distance visual acuity" basis. Normally when discussing outcomes of IOLs only the outcome is based on an "uncorrected" basis. I take this to mean the comparison was made with eyeglasses in addition to the IOLs if they were required to achieve best corrected distance vision. At first that seems off base, but when you think about it, correcting the vision in addition to the IOL outcome is probably necessary to get comparable data. For example if physicians were targeting Eyhance for -0.5 D instead of plano, then of course the Eyhance would achieve better intermediate vision. So, I think it does make sense to correct to plano post surgery to take that effect out. It also takes out all the misses that are the result of the wrong power selection by the surgeon.
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It does seem interesting that they found no appreciable difference, and clearly it is a shot across the bow of J&J, basically saying they are providing a misleading representation of the Eyhance lens capability. I have always been suspicious of the Eyhance claims due to the design where the power of the lens is varied with the radius. The overall design really only works when the pupil is wide open and uses the outer part of the IOL. This of course only happens in dim light, and would seem to imply the increased depth of focus of the lens is only achieved in dim light. I wonder if that is really what people expect of the lens? Increased depth of focus in dim light, or are they expecting increased depth of focus in all lighting conditions?
RicG Lynda111
Edited
Alcon provides a video with Dr. Micheletti on us.alconscience.
It also cointains defocus cures, but doesn't specify the pupil diameter or provide error bars. The curve for Eyhance is not what one would expect, though.
RonAKA RicG
Posted
Interesting graph. The large overlap in the error bars would suggest no statistical difference between the curves.
RebDovid RicG
Edited
Many thanks to @RicG for locating Dr. Micheletti's video presentation. A close watching helps unpack what he means by saying that his study showed the Clareon to be “non-inferior" to the Eyhance for intermediate visual acuity. It also reveals some possibly meaningful differences between the two groups of Clareon and Eyhance patients. (Of course, I’m only a layperson. Someone with training and expertise in the field should be able to provide a better analysis.)
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Dr. Micheletti makes his “non-inferior” remark in the context of reporting that, measuring intermediate visual acuity at 66cm, there was only a clinically non-significant 2.5 letter difference between the Clareon and Eyhance groups. According to the example given by Bard (Google’s AI language model), if a patient's vision is 20/20 after cataract surgery with one IOL, it is likely to be 20/22 or 20/25 after surgery with another IOL that has a 2.5 letter difference in visual acuity. This small difference, Bard agrees, is unlikely to have a significant impact on the patient's ability to see clearly or to perform everyday activities. But it’s a difference some patients may want to consider.
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Dr. Micheletti also says that the Clareon IOL target-corrected to -0.25 D intermediate visual acuity was non-inferior to the Eyhance group’s distance-corrected intermediate visual acuity with a plano target. All else being equal, making the Clareon group slightly more myopic than the Eyhance group would lead us to expect slightly better intermediate visual acuity for Clareon patients. Given that the Eyhance is designed to provide a modest extension of intermediate vision over pure monofocals, which shows up when comparing the Eyhance to the Tecnis 1, it seems a reasonable (at least tentative) conclusion that, without the differences between the Clareon and Eyhance group’s in Dr. Micheletti’s study, the gap in intermediate visual acuities between the two groups would have been even greater (and more in favor of the Eyhance). (Another factor possibly helping the Clareon results is that, while Clareon patients only had a non-toric IOL, the Eyhance group had both toric and non-toric models. Reportedly, this is because at the time of the study only the non-toric Clareon was available. But Dr. Micheletti doesn't explain why he didn't limit the comparator Eyhance group to patients who received the non-toric Eyhance IOL.)
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Two more of Dr. Micheletti’s results, which each of us may want to evaluate in light of these differences between the Clareon and Eyhance groups in his study. First, Distance Corrected Intermediate Visual Accuity was 20/25 or better for 10.3% of Clareon patients and 20/30 or better for 42.6% vs. 25.2% and 58.7% of the Eyhance patients.
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Second, the Clareon only achieved parity with the Eyhance when comparing the Clareon’s Target Corrected Intermediate Visual Acuity, with a -0.25 D offset, to the Eyhance’s Distance Corrected Intermediate Visual Acuity targeted at plano.
RonAKA RicG
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Tried to find the video on the us alcon science site but can't seem to find it. Do you have any more tips as to what to search for to get a hit?
RebDovid RonAKA
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Scroll down to "Clinical Research Summary Videos". Click on "See All Videos". It's currently the first one.
RonAKA RebDovid
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Found it. Thank you.
RebDovid RonAKA
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You're welcome.
Lynda111 RonAKA
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I found Dr Micheletti's bio.
"berkelely eye doctors morgan micheletti"
Lynda111 RonAKA
Posted
And here is a 2023 study (there have been others as well) indicating that compared to the standard Tecnis 1 "pure" monofocal, the Eyhance "EDOF" monofocal provides better near and intermediate distance while maintaining good distance vision.
RebDovid Lynda111
Edited
If you're looking for studies comparing the Eyhance and Tecnis 1, here are some. (BTW, Eyhance doesn't meet the U.S. criteria for an EDOF. I tend to think of it as a monofocal "plus", as compared to "pure" monofocols like the Tecnis 1 (ZCB00) and Clareon.)
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"Enhancing the Intermediate Vision of Monofocal Intraocular Lenses Using a Higher Order Aspheric Optic", Aixa Alarcon, et al., J Refract Surg., 2020;36(8):520-527
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"Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract", Gerd U. Auffarth, et al., J Cataract Refract Surg 2021; 47:184-191
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"Clinical outcomes of bilateral implantation of new generation monofocal IOL enhanced for intermediate distance and conventional monofocal IOL in a Korean population", Wan Kyu Choi, et al., BMC Ophthalmology (2023) 23:157
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"Visual and optical quality of enhanced intermediate monofocal
versus standard monofocal intraocular lens", Nuria Garzon, et al., Graefe's Archive for Clinical and Experimental Ophthalmology (2022) 260:3617–3625
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"A comparison of clinical outcomes and optical performance between monofocal and new monofocal with enhanced intermediate function intraocular lenses: a case control
study", Jungah Huh, et al., BMC Ophthalmol (2021) 21:365
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"Visual Performance and Optical Quality after Implantation of a
New Generation Monofocal lntraocular Lens", Kyoung Hae Kang, et al., Korean J Ophthalmol 2021;35(2):112-119
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"Comparison of an aspheric monofocal intraocular lens with the new generation monofocal lens using defocus curve", Sonam Yangzes, et al., Indian J Ophthalmol 2020;68:3025-9
Lynda111 RebDovid
Posted
Yes, thanks. There are many of those studies. The third one you listed was the one I tried to reference in my post. And yes, the FDA doesn't consider the Eyhance an EDOF, but rather a "monofocal plus."
In the coming years, many more new IOLs will be on the market
RebDovid Lynda111
Posted
An article undergoing peer review for Springer International Ophthalmology reports statistically significantly better intermediate and near vision, without negative patient side effects, for patients implanted bilaterally with the Eyhance as compared to both the Clareon and ICBOO. I've started a separate thread for the article. It's entitled "“Visual Outcomes and Patient Satisfaction after Bilateral Implantation of an Enhanced Monofocal Intraocular Lens: A Single Blind Prospective Randomized Study”. It's available on-line under a Creative Commons Attribution license.