
FDA clears first contact lens with light-adaptive technology - JumpCrisscross
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604263.htm
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rkangel
I'm surprised that a 24 person study was considered large enough for the FDA.
I've only worked with 'proper' medical devices with much greater potential for
harm, but I'm used to trials involving 100s to 1000s of people.

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arkades
They submitted via 510(k), a loophole abused by many manufacturers these days.
They didn’t have to show this device was safe, just that it’s “substantively
similar” to an existing device. The bar for evidence is low-to-laughable.

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castleanthrax
Created an account because I am a medical device engineer. You're
mischaracterizing 510ks quite a bit. A 510k states that a new device has the
same medical indication as a previous device, and you don't have to
demonstrate efficacy via clinical trials. In this case the medical indication
would be "corrects vision." The darkening is a new feature that is not likely
a medical indication.

Regarding safety: You absolutely have to show safety. Any new material,
additive, or processing chemical used for an existing indication must be
demonstrated to be safe. This also applies if a currently used material is
used in larger quantity, or used in a more serious degree of contact (longer
duration, more invasive). This is done through biocompatibility testing in
accordance with ISO 10993.

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dx034
Not sure if that's a great idea. If you wear sunglasses (or light-adaptive
glasses), you can still take them off quickly. E.g. when driving against the
sun and entering a tunnel, taking off the glasses help to be able to see the
road. With contact lenses, I could imagine that you'd be basically blind for
at least a few seconds?

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bdamm
When wearing transitions I would often remove my glasses and pocket them a
minute or two before entering a building, so that I could don the glasses as
soon as I entered. When riding a motorcycle while wearing the glasses the
darkening was significant and was unnerving to ride from a bright section of
road to a deeply shadowed section. The effect was similar in a car but
windshields do block more UV than a visor.

If someone is willing to wear contacts I can't see why they wouldn't just don
sunglasses. Intriguing product but uncertain of what applications exist.
Perhaps the deeper meaning here is the additive process. Also noteworthy is
that the dye could be laid unevenly so that some areas of the contact are more
affected, such as only in the top 1/3rd.

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delinka
"...such as only in the top 1/3rd."

Contacts don't stay "upright" in the eyes, so I'm unclear how this would be at
all beneficial.

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thefifthsetpin
Most don't, but they do make lenses for people with astigmatism which maintain
their orientation.

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cptskippy
I have those, I don't think this would be a good use of that because the
contacts don't orient themselves very quickly when put in and they're easily
reoriented in your eye by simple movements.

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bdamm
You have the wrong brand then. Check with your optometrist because I can
assure you, you don't have the live with that problem. It can be fixed.
Contacts should retain their orientation at all times unless under extreme
duress like you just slept all night in them.

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jupiter67
What I'm wondering is how noticeable that will be to other people. Could be
weird talking to someone while the contacts are still darkened.

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craftyguy
I presume it would make your pupils look super dilated, which could have all
sorts of fun implications...

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duncan_bayne
Shades of _A Gift From Earth_ there. Good novel.

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tastythrowaway
When can we expect to see these available?

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fragsworth
This seems like a bad idea. Our eyes have adapted to living with sunlight for
thousands of years.

I have a feeling it will be discovered that there is something wrong with
darkening your vision for long periods of time.

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magduf
Thousands of years ago, people didn't generally live much past 30 years old.
UV has been proven to have negative effects that show up later in life than
that.

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jessaustin
Where on earth are you getting this? It was certainly _not_ rare for
paleolithic women to see their second and third children live to adulthood.

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magduf
A paleolithic woman would have had her 3rd kid at around 20 years old tops.
Seeing that kid to adulthood is still less than 40 years old. Age-related eye
problems don't usually show up until you're over 40.

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jessaustin
Oh I thought the proposed expectancy was 30; 40 is more plausible. Also, a
third viable child produced by 20 indicates a fairly rosy local situation.
Every viable child would have nursed for at least two years. Infant mortality
was much higher. Menarche took place later than in modern humans. Famine was
more common.

One might think that would simply mean that fertility was lower than I'm
proposing, but if you look at what paleolithic humans did that is simply
impossible. On foot, they occupied every part of every continent save
Antarctica. That required fertility significantly above replacement.

