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
valerio01538 rwbil
Edited
I could be wrong, more. from the little information that I have obtained about Juvene, it seems to me that it is a lens that has a young audience as its target. For it to work well, it is important that the ciliary muscles are in perfect working order, a more favorable situation for a younger person, or those under 40 years of age. As we know, over the years, the lens begins to lose its flexibility, becoming more rigid to mold itself according to the visual need, and the ciliary muscle is no longer able to contract with ease to sufficiently increase the curvature of this natural lens ( this is prebiopia). That said, I'm not sure after years of presbyopia, followed by more years of cataracts, a person would be a candidate for this lens, as it needs all the energy from the ciliary muscles. I wish I was wrong...
rwbil valerio01538
Posted
That is an interesting theory. I thought presbyopia was not caused by the Ciliary Muscle not working but changes to the lens itself as we age, but I have not really researched this topic.
If you are right then it would seem to be a flaw in the Juvene IOL. Be interesting to see what others say or if there is an article on Juvene about this particular issue.
My only thought is why would anyone get the Juvene if it will suffer from Presbyopia.
valerio01538 rwbil
Posted
The thing is, we know that our muscles weaken as we age, apart from that, we also know that muscles that are not used for a long period of time atrophy. With the advancement of lenses, more and more young people have become interested in replacing their natural lenses, simply to get rid of glasses. I think these lenses would be for them. At the onset of presbyopia, the ciliary muscles would still be in full force and would make the lenses work well. Knowing that a young person has a long journey ahead, the lens must allow for updates. As it is made up of a base that sits in an open capsule, this allows for easier lens replacement, allowing for improvements to be made over the years. Does not make sense?!
rwbil valerio01538
Posted
All I can say is interesting. If I understand you correctly Juvene needed a modular base and easy IOL replacement as the IOL would need to be replaced as a person ages with a Juvene IOL that adjust differently based on the strength of the Ciliary Muscle.
Trying to expand on this theory wouldn't your Ciliary Muscles be weaker or stronger than my Ciliary Muscle therefore would we not need 2 different Juvene's adjusted for our individual Ciliary Muscle contraction strength.
I frankly have no idea, but be nice to see a doctor do a write up this topic.
And I would add this any / or other issues is the risk with a revolutionary new IOL. You just don't know until you know. Maybe it will be like the Crystalens which had high expectation and turned out to be a flop.
valerio01538 rwbil
Posted
I have no doubt that, just as one or another eye problem disqualifies a person for one or another type of lens, there must be situations that will disqualify candidates for Juvene, only experience will answer that question.
walt96545 rwbil
Posted
As a 30 year old, this lens is the only reason I haven't had surgery yet, but I don't know if I can wait until 2023 or possibly later. One of my eyes is extremely sensitive to light already, forcing me to stay inside during the day, and the other eye isn't doing that great either.
rwbil walt96545
Edited
There are a lot of unknowns about the Juvene IOL. It has only been implanted in a few people.
If both of your eyes are bad, IMHO I would not wait and I would think you would want to at least have 1 of them done and then can procrastinate as long as possible to see what new IOLs come on the market for the 2nd eye. That is what I did. I could basically only see out of one eye and could not even make out the Big "E" with the other eye.
The good news is there some pretty good options out there that the vast majority of people do well with. It is about knowing what is out there, the tradeoffs and deciding what is best for your particular situation.
If you don't have other eye issues and are OK with dysphotopsia, there are diffractive IOLs like the PanOptics. And there are the new premium Monofocals like the Vivity.
My number 1 top advice is see a Top Doctor who has lot of experience implanting all the different IOLs. One can start by looking at the Newsweek's Best Eye Doctors list. Give them a call or email and see how they respond to your questions and if you have a good rapport I would go that doctor even if it is a days drive.
RonAKA walt96545
Posted
If you decide to wait you may want to get your eyes measured before the cataract becomes too bad. It gets more and more difficult to get good readings as the cataract gets more dense. I would suggest you go to a surgeon that you like and has a IOLMaster 700 to measure with, and will agree to keep your measurements until you decide what you want to go ahead with.
andibagus rwbil
Posted
Hello, I'm in Europe and I want to be enrolled in Juvene trials.
My case is so particular that should look interesting.
Please help me find where I can ask.
rwbil andibagus
Posted
In the US there is the FDA clinical trial website, where you can see what trials are going on and then contact the doctors participating. It also list trials being done in other countries.
Doing a quick search it looks like they have something planned to start in 2023.
You could also contact the company directly and inquire about their clinical trials.
But one warning sometimes clinical trials do not do what you want as they usually want a control group or something to compare results to. So they might put a monofocal in one eye and the Juvene in the other.