Upcoming Cataract Laser Surgery. Doc is recommending Oculentis Comfort lens. Are they safe?
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I have been scheduled for cataract surgery in the coming month for both my eyes. Doctor recommend using Oculentis Comfort ioL. I have concerns about using Oculentis due to the clouding of the lens and 2 recalls in the past years. Another concern of mine is when I search Oculentis on google and youtube, there are no recent videos or articles on the product. As if its been rubbed from the internet or the product is generally not being used. In which case, why would my Opthamolgist recommend it?
My details.
45 yrs of age with diabetic retinopaty. Dont wear glass but do have issues seeing long distance. Never been a concern as ive never had any reason to see 200 yards out for accuracy. Looking for an IOL to fit my lifestye of 8+hrs daily on average of computer, phone and reading use. Sight is fine for near and intermediate at this time. Distance is the only issue. I do see halos and glares are night and feel like ive seen or dealt with them for a major part of my adult life.
Is Oculentis comfort series a reputable lens or should I avoid it altogether? Have they fixed their issues with the bad lens? My doctor did not give me another choice. But from research, I feel the Eyhance or Vivity might be choice for me.
Any feedback would be much appreciated.
0 likes, 8 replies
RonAKA dj2327
Edited
I have never heard of that company or seen anyone report experience with that lens. It appears to be a company based in Netherlands, so perhaps some of the European contributors may know about it.
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From what I see of the specifications on it, the Tecnis Eyhance and Alcon Vivity would appear to be somewhat equivalent offerings from J&J and Alcon. At least in North American they are the two "big guys" in the business. Both the Eyhance and Vivity are quite new in North America so there is not a huge amount of experience with them either.
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The Eyhance adds about 0.5 D of extra depth of focus, while the Vivity is about 0.75 D extra. The Eyhance does not add quite enough to be called an EDOF but Vivity does. They are the most mild forms of IOLs to help correct presbyopia, and should have the least side issues.
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Monovision is another option to achieve reading while using monofocal lenses or one monofocal and one EDOF. I have a Alcon AcrySof IQ monofocal in my first eye, and have been looking at another one undercorrected by -1.25 D for the second eye, or perhaps a Vivity undercorrected by 0.75 D. I am currently simulating monovision by using a contact in my second eye, and I kind of like it.
Sue.An2 dj2327
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There were several a couple of years ago that had that lens (and they did cloud). I cannot recall their names (this would 3 yrs ago). There are many lenses on the market - if it were me based on past history I would go with a different lens.
Are you having this surgery due to cataracts?
dj2327 Sue.An2
Edited
It was an UK article about the Oculentis Mplus lens that had production errors leading to calcification of the lens post implant 5 to 7 yrs later. They did a recall twice on the lens with the latest being lens that expire May 2020. That to me is pretty recent and I feel uneasy about that date being so recent. My Opthamologist only gave me this choice as a recommednation. I have put in a call to talk to him before making my decision and am thinking of getting a 2nd opinion.
I am having the surgery due to cataracts. I was fine up until about Feb 2021 when suddenly I had cloudy issues in my vision. I do have diabetic retinopathy. The cataract came on suddenly and I am assuming is the type that grew quickly.
I am going to request a different premium lens and hopefully I am given a choice. If not, I hope I dont have to find another doctor. He already treats me for my macular degeneration.
Sue.An2 dj2327
Posted
I just sent you a PM with a link to the thread from dealbreaker who had issues with those lenses in 2017. Not sure they are still checking in here from time to time or not.
Yes It would make me uneasy too to go with a lens that has had a couple of recalls. Each surgeon usually has their go to lens or two that they are comfortable with so hopefully he has another one to suggest so you don't have to go with another surgeon for 2nd opinion.
RonAKA dj2327
Posted
It is a bit of an awkward situation when you have a doctor that is pushing lenses that you don't really want. If you push the surgeon to use a lens they are not skilled in implanting they may not do a good job. It would be best to find a surgeon that offers and recommends the lens that you want. Then they are invested in making it work for you.
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Don't be fooled by the term "premium". This is a name given to lenses that correct astigmatism and presbyopia. The only true premium feature of the lens is that they are sold at a premium price. That does not ensure higher quality vision. And in fact in most cases they compromise quality of vision to allow you to see at a wider range of distances. It is not a simple trade off but in general the wider the range of focus that they offer the more potential they have for adverse effects. It is not a simple, pay more and get more.
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It kind of comes down to your awareness and tolerance for side effects associated with the increased depth of focus they offer to be mostly or totally eyeglass free.
Guest dj2327
Edited
Been reading about Oculentis this morning. I'd always been aware of it but dismissed it for being weird (asymmetrical and odd looking haptics). But the data on it looks amazing. No contrast loss, very minimal glare, no halos, and a great defocus curve. Is the only downside the opacification issues they had? Or are there also optical design downsides as well? They say they have definitively identified what the issue was (a cleaning solution used during manufacture) and fixed the issue.
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The most interesting thing about the IOL which I didn't know is that it's fixated differently than a normal c-loop haptic IOL. A normal c-loop IOL is just kind of spring loaded to press on the inside of the capsule membrane. But the healing process (shrinkage and fibrosis) can lead to tilt and decentration. These IOLs are often implanted through a manual Capsulorhexis. Manual means they literally just tear a hole a opposed to using a femtolaser to make the capsule opening. Which is fine. Femto is largely considered to not be worth the cost.
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Anyway this IOL does not do that. It relies on the perfectly circular and centred Capsulorhexis you can achieve with a Femto to CLIP into the Capsulorhexis itself?! It's not pressing against the inside walls of the capsule, its literally just clipped to the opening they make in the front of the capsule to remove the cataract. Wow. Pretty cool actually. And becasue a femto 'rhexis is perfectly centred, the IOL also remains perfectly centred. It would be more expensive though because you HAVE to use the femto laser for this IOL.
dj2327 Guest
Posted
Thank you for your insight. From all the research I have done, outside of the agent they used in the plant that induced the calcification, the lens itself seems like the best EdoF on the market that deliver the most contrast without the great affects of halo and minimal glare.
My line of thinking was if I were to go ahead with this iOL, and did have clouding early one, it would be because of CPO. If it happen much later, it would probably be the same issue as the calcification of lens in which case I would implore my doctor to ensure we never did YAG and just replace the lens. From what Ive read, its possible to do an explant of a lens post YAG, its just most doctor do not want to or not williing to risk it. Yet it is done in some cases like the those who Oculentis paid to explant due to the past issue.
My doctor is good. I like him and trust him. But at the end of the day I may choose the less risk option and choose another lens. I am 45 and fairly young for cataracts thus Im certain I will need YAG as it is much more common to get clouding in younger eyes.
Guest dj2327
Edited
To be honest, given their legal troubles from the TWO recalls and the very novel design I'm not sure I would put it in my eyes. Even if the clouding issue has been fixed. But it is a very interesting and different lens. I'm curious, but would proceed with caution. I wonder if the weird half & half design makes it hard to get glasses after surgery to correct and residual refractive error?
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But anyway, it is interesting. I'd be interested in talking to a surgeon about it but I still think I'd personally lean more towards the newer refractive options on proven platforms like Vivity (Acrysof IQ) and Eyhance (Tecnis). I really do think the contrast concerns about Vivity may be overblown (which might be my fault… I've posted about it a lot here).
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Good luck with your choice. I'm in the same boat and very close to the same age as you. And I still haven't decided. It's a tough decision since there's no way to test drive these things.