Juvene IOL Get FDA approval to begin Clinical Trials
Posted , 12 users are following.
Finally, the Juvene IOL get FDA approval to begin Clinical Trials.
So if you are willing to be the guinea pig for this revolutionary adaptive IOL now might be your chance.
This could be the first adaptive IOL that works to provide close to distance vision with no Trade-offs. In fact what makes this IOL super cool is its modular base which could eliminate PCO and allow one to easily exchange IOLs. Though I am not sure it would work with other manufactures IOLs or not.
It looks like they are now in the process of raising funds for the clinical trials.
My only advice is if you decide to get in the clinical trials and don't live near the doctor's location, other doctor's in your area will know nothing about this IOL if you have a problem. I know this as it happened to someone I know who entered a clinical trial for an IOL that was not approved
Darn I wish I could have waited a few more years for this IOL to be approved and have some time to see Real World results. You have to be a super early adapter for this one.
You can read up on this and the Grail Study from the links below:
Eyewire: "LensGen Receives IDE Approval from the FDA to Begin Clinical Study of the Juvene Presbyopia-Correcting IOL"
Opthalmology Times: "LensGen receives IDE approval from FDA to start study of Juvene presbyopia-correcting IOL"
Opthalmology Times: "Grail Study shows refractive stability of Juvene IOL"
2 likes, 28 replies
Guest rwbil
Edited
OMG. WOW! Still it will probably be years yet before commercialization right? Still amazing. I've been delaying my surgery for a year now waiting for the public health system in my Province to offer the Eyhance but this is amazing. I decided on Eyhance over Vivity because I'm not too keen on the dim light / contrast trade off with Vivity. Plus it means I can go public and get the surgery for free instead of $6000. This makes me wonder if I could wait a little longer? But I imagine Juvene is still years away. I can't wait much longer.
rwbil Guest
Posted
I don't know a whole lot about the Juvene. I am an early adapter as I got Synergy shortly after commercially available, but not this much of an early adapter.
From what I understand it is a fluid lens. How do you know how well it will last until years of Real World results with thousands of patients.
But if all goes well it would be revolutionary and the IOL of the future, but that is a big if.
RonAKA Guest
Posted
Which province are you in? I would be surprised if public health would offer the Eyhance at no extra cost. It is a mild EDOF (although not technically qualified as an EDOF) but not a monofocal, and I'm sure J&J will want more money for it. Where I am in Alberta the Clareon is a pure monofocal but still costs $300 more than the AcrySof IQ monofocal.
gmag21 Guest
Posted
i've been following this lens for a while myself. I read an article last year that LenGen is targetting 2023 as a preliminary date for commercialization. I have a need for cataract surgery on my right eye but can probably hold out another year or two before i totally have to. I really want this IOL for my other eye (its dominant). My left eye has a multifocal from 2007 and i hate the side effects (but do enjoy the benefit of a second focus point)
rwbil gmag21
Posted
I was in the exact same boat. MF in left eye and kept waiting for a better IOL to come out. Vision in other eye was not even 20/200, so when Synergy came out I went with that as no clue how long until Juvene is approved, that is if it is approved.
Except for revolutionary vaccines, the FDA does not move very fast. Just look at the LAL. It seems like it took forever to go from clinical trials in Mexico to being used in the US.
And lets say the FDA approves this IOl based on a clinical trial of 50 people or so, are you willing to be one of the first people to test this revolutionary lens? Not exactly the same, but the FDA pulls 1000s of FDA approved drugs off the market as long term results turned out not to be so great as clinical trials.
Having said all that I am a procrastinator, so if you can still correct your other eye such that you are good with it then hold out as there will always be newer IOLs coming out.
gmag21 rwbil
Posted
Lucky for me I can still correct to 20/20 on my right eye but the glare from light sources is becoming more & more problematic (particularly at night). Maybe I can hold out for longer than I think and allow the market have a chance to test out these new IOLs.
Guest RonAKA
Edited
I'm actually not sure if it will be free or not but I'm told the lenses WILL be available soon. Once it's available they will let me know if there is any additional cost to me. We actually don't know at the moment. But even if it's $300 or more I still consider that basically "free" vs. paying $3800 to get Eyhance from a private clinic. Personally I don't think the marginal improvement of Eyhance vs. a monofocal is worth paying that much. I figure if I'm paying that much I'd probably rather go with Vivity for $1800 more (no offset) and just hope for the best in terms of contrast and near(ish) vision usefulness.
RonAKA rwbil
Posted
If it works it will be a breakthrough. I have to remain skeptical though until the trials are done. It would take a lot of nerve to be a trial participant when the outcome may require an explant of the lens, with all the associated complications...
Guest RonAKA
Posted
Trials have been done though. We have data from those trials. Just not a USA trial yet.
hanah rwbil
Posted
Any trials of the Juvene IOL in the UK?I have to have my cataracts treated so I would like to know if it's coming to the UK?Thank you very much fir any information!
rwbil hanah
Posted
Not sure about clinical trials in other countries. You can try and search the equivalent of the FDA in other countries for their clinical approved trials. But my top suggestion is just contact Lensgen directly and ask them.
I would also advice to really think about this and do a lot of research. There have probable been less than 100 people or so implanted with this IOL. And this is not just another IOL making minor improvement. This is a revolutionary new IOL and IOL system. It uses a modular system.
On the good side the manufacture is going to use top doctors for the clinical trials as they want their results to be as good as possible.
I would get your list of question down to ask about this IOL. This IOL system uses a modulcar base that keeps the capsular bag open, which can theoretically have benefits like low levels of PCO and make exchanging lens much easier.
One thing I would want to know is if there is a problem with the IOL can just the IOL be removed and another implanted and which other ones work with their modular base. I doubt you could just put a PanOptics on the Juvene modular base, but that is something to look into.
Or would the IOL and the modular base have to be removed and what that entails.
One of warning, if you get an IOL implanted in a clinical trial and then that IOL is not approved, you might have a problem finding a doctor close to you that knows anything about it if there is a problem later on.
hanah rwbil
Posted
Thank you for your reply!I hope I can wait a bit for this lenses to be available in the UK.Where is the Lengsten based?I am quite new to it as the news that I have cataracts ready to be removed sprang on me last week!I am doing a lot of research now and I am not happy with options available so far as every lens has some deficiency in their performance .I am scared to make a wrong choice!
rwbil hanah
Posted
I think Lensgen is out of CA. You just heard you had cataracts last week? What is your current corrected vision? I am a procrastinator and if your vision is still acceptable I say wait. But remember I was worse than 20/200 before I got surgery.
I say wait as long as possible, as who knows what new IOLs might come available.
BrianCyberEyes rwbil
Posted
As someone whose only options so far are Monofocal IOLs, due to Retinitis Pigmentosa and Glaucoma, would a lens like the Juvene (once approved, etc.), even be a theoretical choice, or would I still be recommended not to dream and just stick with simple solutions?
RonAKA BrianCyberEyes
Posted
I am not optimistic that Juvene is going to be a proven option in the reasonable future, unless you can wait several years. You may want to look into mini-monovision. It uses basic monofocals but can provide a wide range of vision.
rwbil BrianCyberEyes
Edited
I don't know. It is a modular system so could that make a difference, again I don't know. And frankly even if approve on clinical trials, that is not a lot of people who have had it implanted. It could be sometime after that before risk are known.
BrianCyberEyes RonAKA
Posted
I'm a bit afraid of any type of monovision as I have always seen better with both eyes than with any of them individually (I know there's a term for that, but it eludes me), i.e. my vision with any eye on its own isn't stellar but combined it is serviceable, to me.
I'm not 100% sure but I hope having both eyes set for the same target refraction would serve me best.
I'll just have to do with readers for phone and PC, or progressive glasses if it doesn't turn out optimal in terms of astigmatism, etc.
RonAKA BrianCyberEyes
Posted
It is easy to simulate mini-monovision with contact lenses before you consider doing it with IOLs. Fully correct your dominant eye with a contact. Then under correct your non dominant eye by 1.5 D. For example if your eyeglass prescription for your non dominant eye is -3.0 D, then use a -1.5 D contact. That will give a reasonable feel for what monovision is like. It can allow you to see near and far without glasses.