Ex-FDA Advisor Says of Lasik Eye Surgery: ‘It Should Have Never Been Approved’
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Chronic pain is usually related to dry eyes. Those patients should not be operated at all. Bad patient selection can result in terrible results.
Loss of visual acuity after refractive surgery is more than exceptionnal. It is usually manageable with hard contact lenses.
The special thing about refractive surgery is the contrast between its apparent easiness (non specialist eye surgeon will often refer to it as an "easy surgery, no technical difficulties") and the rapidity with which hard to treat complications can occur if everything does not go as planned. Little things (water drop on the cornea during the treatment, centration error, mismanagement of flap cut incidents...) can lead to disasters that you sometimes cannot repair.
A decade back, my SO worked on clinical trials at a research hospital in the eye clinic. I understand nothing about this stuff.
However, I gleened one important bit of advice:
Avoid any surgery, procedure that surgeons themselves avoid. My SO claims that eye doctors avoid LASIK.
Maybe 10 years ago, a visiting eye doctor was lecturing about LASEK (not LASIK), an operation he had done on himself, and other doctors took note. That was evidence to my SO that LASEK was worth considering.
https://en.wikipedia.org/wiki/Photorefractive_keratectomy#LA...
Again, I know exactly nothing about this stuff. I am not saying to have LASIK or not. Progress marches on and I'm certain techniques have improved.
But I do think this is a good universal heuristic. So am encouraging patients to ask their care provider if they'd get it done themselves.
Eye surgeons not getting surgery was totally true 15 years ago but it is not anymore (at least in France)
I got LASIK in September of 2018, I did my 1 year checkup in September of this year and am seeing 20/15. I used eye drops as instructed and now I don't need them. I still use readers for little print (or more light), but I knew I would need to going into this.
No regrets, except I should of done it years ago.
The gas-permeable ones were from ye olden times, I don't think most people need to bother with those anymore because materials for soft lenses these days admit much more oxygen. They were also by far the least comfortable.
The extended wear ones were an amazing transition after the previous ones. Barring manufacturing irregularities in any particular contact lens, a few seconds after they're in your eye, you can genuinely forget that they're there. My issue with these was mostly psychological: removing them every night and cleaning them proved to be annoying enough that I would justify just sleeping in them for one night. The second day was much more uncomfortable (dryness mostly). Subsequent days would be miserable, but I seldom made it all the way through day two.
I finally switched to dailies and they are even thinner (read: more comfortable), and it's effortless to take them out and switch to glasses when I'm ready for bed, so I very very seldom end up sleeping in them. (Also, if one happens to fall on the ground or get torn, it's not like you're losing a week's worth of wear on it, you were going to throw it away anyway that night. Just having that peace of mind is nice.) Finally, when traveling, I don't have to pack the travel size contact lens solution and lens case, I just bring however many days' worth of lenses (they come individually packaged). It's been amazing and I recommend it.
If the thought of having something in your eye seems weird, maybe try a trial set. Optometrists (at least all the ones I've used here in the US) will give you a pair of extended wear lenses or roughly a 10-pack of dailies to try out, so that you know how they are before you commit to a year's supply. They'll also generally coach you on inserting/removing. It was awkward for the first month but now it's just a part of my routine.
I work between two offices at the moment, so I keep a few pairs in both desks just in case as well as a pair in my car. I considered going back to glasses before I got dailies pretty much out of convenience alone, but I hate glasses as you don't get an undisturbed field of view and the lens distortion at the edges usually give me motion sickness. Having some dailies really is the best of both worlds.
The reason I switched to contacts was because this effect was so bad that I felt like it was difficult to hold eye contact with one person, and any group conversations had me swinging my head around to point my chin at whoever was talking because otherwise I couldn't meet their eyes. It was very isolating.
Then for years I wore the disposable, extended wear kind you can sleep in. Typically replaced every two to four weeks. Aside from dry eyes in the morning, these were by far the best.
They are not without risk and certainly not for everyone, but they had the highest manufacturing quality, were the most comfortable and seemed to me to provide the best correction.
For the last two years I’ve worn daily disposables. I think these are probably best for eye health since you’re not reusing one set over and over and not leaving them in for days on end, but they have the most variation between individual lenses. Sometimes I’ll get contacts that are instantly irritating. The next in the package will fit comfortably. Quality of correction varies every day too. This I just live with, as it’s not worth (to me) burning through them faster just because my distance vision isn’t as good as it could be today.
I’ve always used whatever brand my optometrist recommended (which I’m sure is whatever they’re being paid to promote). If there is some gold standard brand I should be asking for, I’d love to know.
Dailies changed my life. They only started making dailies in something close to my prescription a few years ago.
If there's anyone else who have got close in terms of comfort, quality of vision etc, it's a well kept secret.
That helps confirm someone else's comment that this differs by person, not manufacturer. I kept trying Acuvue and found them very uncomfortable, instead favouring Focus Dailies. Now I am on Costco own brand which seemed even more comfortable.
If it's not Acuvue for soft contacts it's almost always going to be one of the CooperVision chain brands.
Also, the drops make huge difference: since a better doctor told me to use only preservative-free ones like hylo-comod, I can wear lenses for 20 hours straight without image quality degradation.
Of course, they were just a recommendation by the optometrist, I wore a pair of trials and they were good enough that I stuck with it.
I once had contacts, they did work OK. My issues were that i suck at putting things in my eye. I never got comfortable putting them in, i know that is a personal issue not the fault of the contacts. Also my contacts had to be weighted for some reason (i cannot recall why), and if my eye got dry they would shift and things would become blurry and i had to use eye drops or tear up (didn't happen a lot, but enough to annoy me). Plus i still needed a set of glasses.
Kind of off topic, my other half, she was making fun of my reading glasses, one day she was struggling to read something and i slapped them on her face and her response was OMG. I laughed, went to take them off her and lets just say i had to go buy myself a new pair (she confiscated them). It is interesting that people think readers are only for older people or you need a prescription, she wishes she would of gotten a pair 5 years ago.
I have astigmatism. I had the same problems with older-generation contacts.
I switched to Alcon's top of the line daily disposable contacts and now my contacts almost always line up correctly. The new contact lens technology is amazing.
Somewhat surprising because I am very near-sighted and have astigmatism.
If contacts weren’t as good a solution I probably would have gone for laser surgery. I hated wearing glasses - the biggest aspect was how they distort your vision a little. I can see much better with contacts than glasses.
But then when I got older I started getting more eye infections and each time you can’t really use contacts as it irritates the eye, so back to glasses.
And then I started reading a bit more about how you can get resistant bacteria infections from contacts (basically guaranteed blindness) I realized I was risking my eyes each and every day anyway, better to bite the bullet and go for a surgery. Risk once and be done with it.
I think the feeling of freedom and one less thing to worry about that I got after the successful LASIK was akin to when I first switched from glasses to contacts. I think its totally worth it.
(https://medium.com/@ivankerin/a-humble-mans-account-of-the-l... a bit more in depth account if anyone’s interested)
1. I couldn't rub my eyes anymore in public. Rubbing my eyes would often end to with one of my contacts in my hand.
2. I had to always plan when I was going to sleep. This pretty much made napping impossible. Going to sleep with contacts was horrible.
Are there better contacts where the above two problems aren't an issue?
Yes. I wear extended wear contacts that are supposed to be replaced once a month. I take them out and replace them when I notice a significant deterioration in vision, or when my eyes feel scratchy. For me has varied between a month and about 18 months. YMMV
I have very occasionally rubbed my eyes to the point of accidentally removing a contact, mostly this is a habit I have trained myself out of
Most days and nights I forget that I have contacts in, I always sleep in them, makes getting up in the night to pee much safer, and other night time activities more enjoyable
>makes getting up in the night to pee much safer
Is that really the case? My vision is only slightly better than yours (although my last check was years ago) and I feel like I could do most things without glasses just fine. Anything that requires reading is difficult though, unless it's on my phone where I can just bring it very close to my face.
On a more serious note, when a fire alarm has gone off in the middle of the night and I have to grab a sleeping child and get out of the building, then it's one less thing to worry about for sure
The SiHy's had a bit of a tradeoff though, despite being able to let a lot more oxygen through (which the corneas need, they can directly absorb it), they are not inherently wettable. Silicone is hydrophobic, it naturally repels water. So 3 generations of silicone hydrogel are in use. 1st gen has an external wetting agent that rubs off over time. 2nd gen has an internal wetting agent that some people are allergic to. 3rd gen has the molecular structure arranged in such a way they are inherently wettable.
I wear 3rd gen SiHy's now. Cooper Biofinity is the name brand. These are approved for extended wear up to a week. I have done longer than this but risk of complications increase. However, these were a huge improvement over the regular hydrogels I used to wear. If I had them in over 17 hours or so my pupils began to dilate from my eyes being oxygen starved. They are a little stiffer (and hence, slightly less comfortable than my regular hydrogels were). They also have a slightly higher chance of feeling dry due to higher water content than most other SiHy lines.
Anyways, hope that helps. There's a lot of options on the market and for you it might be better to look for a higher water content with lower stiffness, if you need to wear them when sleeping that really limits you to 4 or 5 continuous wear brands. Don't wear a non-approved regularly for sleep, it'll screw up your eyes in a mess of different ways (vascularization and such).
Now, what I wish I had known is that apparently a knock to the head can dislodge the flap. Still would have gone for it.
Edit: I do have a bit of halo at night with bright lights. A total non-issue for me as my lenses were always scuffed, causing more halo that I get now. And I'll take an eye drop once a quarter or less.
- no flap, they remove top layer of cells with a scraper, then laser
- no flap means stronger eyes. if you box, mountain bike, work in a high risk environment, it's the procedure to get
- long recovery time, and it's pretty painful for the first week. ~ 2 weeks to reasonable vision, 4-6 weeks for 20/20 or better.
- less chance of dry eyes (still a semi-common outcome)
My complications:
- dry eyes, but nothing worse than contacts get midway through a day
- sensitive eyes. meaning, a scratch on the eye becomes eye wateringly bad
- slight halos at night, but again, nothing worse than contacts at the end of the day
Search the rest of this discussion for PRK. If you aren't afraid of pain, discomfort, and a long recovery time, it's the procedure to get.
Also there's a HUGE difference in lasik or PRK providers. As you can imagine, it's worth spending extra. My procedure cost $4k total, which is $3k more than budget lasik providers. However, I worked with some top eye doctors that regularly perform serious eye surgery, and are at the forefront of optometry. Strip mall discount lasik has less time spent on planning, comes with less experience in recommending procedures, and has less experience working with complications. Definitely don't cheap out!
I got PRK in somewhat unusual circumstances, paying $1.6k total. My cornea thickness was compatible with the procedure (which is one of the big reasons to do LASIK over PRK, i think), but my offset was huge (-7.5, where PRK usually caps at ~-5).
The circumstances boil down to having it done in a foreign country, and they used a non-FDA approved eyedrop (toxic if it got in the bloodstream) that allowed the procedure to correct my offset fully. Four years later my vision is going strong.
Long recovery time was 2 weeks with fireworks in my eyes the first two days. After that it was logrithmic improvement in blurriness.
I would also highly recommend PRK, it enabled an entire lifestyle for me which heavy glasses actively discouraged, and there isnt a day i miss waking up to a blurry space.
This is so important for any surgery where mistakes can be life-altering. When I was a teenager we cheaped out on braces with a dentist 3x cheaper than the other one we'd spoken to, and my teeth are now slightly misaligned and I have a fairly weak bite.
Fortunately it doesn't affect my outward appearance and I've gotten used to it as it's not too bad, so it was almost worth it for the valuable life lesson.
I don’t believe it’s as simple as finding a more expensive provider to ensure better outcomes.
I don't know how you find the best in your area, but I was mostly referring to the strip mall lasik centers. If you aren't familiar with these, they are a budget lasik provider that has past generation equipment, run by technicians instead of eye doctors. They run ads on billboards, and in the local coupon books that are delivered to your house....These are the places that I think are mostly being referred to by the article.
Most doctors will use the same equipment in the same area. For PRK they do a tomographic scan of your eye to determine a number of parameters, and then your doctor pre-programs the procedure.
In my case, the most direct action my doctor had during the procedure was cut back/replace the outer flap, and apply the drops.
I say this because 'cheap' (at least to me) implies someone with less skill or lower ability performing for a lower price. Since so much of the process is automated I'd say that only a small part of this applies.
Especially for those who are looking for a good price, ask revealing questions like where the equipment is, when it was recently obtained, how often this particular doctor has done it. And since costs aren't directly attributed to manual labor (and can easily crest 10k+ for a region), dont be afraid to negotiate and price compare.
This is the main reason why I'm sceptical of laser eye surgery and contact lenses - even if you have 20/20 eyesight, there are a lot of circumstances where you should be wearing protective eyewear anyway. Laser eye surgery makes your eyes more vulnerable to damage and doesn't obviate the need for protection from dust, debris, caustic substances and UV radiation.
Here is what article singled out: “In a recent study, the FDA found nearly half of participants who had no visual symptoms prior to the surgery reported having some complication three months after surgery.”
AND here are ALL the conclusions from the linked study results:
* Up to 46 percent of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.
* Participants who developed new visual symptoms after surgery, most often developed halos. Up to 40 percent of participants with no halos before LASIK had halos three months following surgery.
* Up to 28 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. This is consistent with previous studies. * Less than 1 percent of study participants experienced "a lot of difficulty" with or inability to do usual activities without corrective lenses because of any one visual symptom (starbursts, ghosting, halos, glare) after LASIK surgery.
* More than 95% of participants were satisfied with their vision following LASIK surgery.
* Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider
So what this means is that more than 50% of participants of the study had NO visual symptoms 3 months after the surgery and including those that did have some symptoms, 95% of ALL participants were happy with the outcome.
Add me to those 95% -- I had my Lasik done a decade ago at the Stanford Eye Center and had a quick recovery with zero complications and zero side effects
[1] https://www.fda.gov/medical-devices/lasik/lasik-quality-life...
It finally convinced her, when several consecutive days I had what she described as "halos" because I was tired and could not properly focus at late night.
Myself having a nearly perfect vision at the time never paid attention to them before she expressed her concert about that effect after surgery.
I suspect it is a very mild form of post-surgery paranoia. I have a very similar thing after a minor surgery in the abdomen area: I started paying waaay more attention to what happens in my stomach.
https://www.eyeworld.org/article-marcus-welby--md--knew-best
"Even though the FDA had already made up its mind to ban IOLs, the directive came down from Congress that you can study IOLs, but you can't ban them."
>they were shooting very hard for control. They said intraocular lenses are drugs and the FDA needed to control drugs
He is one man giving his opinion on what the opposing side was thinking during a debate over thirty years ago. The FDA likely had legimate reasons to continue their fight, they aren't actively hoping people can't see.
Why would you undergo elective surgery if you had zero symptoms?
You can find negative experiences, sure, but what is the actual incidence of that? Without that data, this is utterly meaningless. It certainly isn't damning.
A recent clinical trial [2] by the F.D.A. suggests that the complications experienced by Mr. Ramirez are not uncommon.
Nearly half of all people who had healthy eyes before Lasik developed visual aberrations for the first time after the procedure, the trial found. Nearly one-third developed dry eyes, a complication that can cause serious discomfort, for the first time.
The authors wrote that “patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.”
[1] https://www.nytimes.com/2018/06/11/well/lasik-complications-...
[2] https://jamanetwork.com/journals/jamaophthalmology/fullartic...
Dry eye is hell especially if you work at a computer.
As an aside, Ocusoft Retaine drops are the best thing I’ve found for dry eye; I’ve never met anyone else with the problem who uses them but it’s like night and day.
For anyone reading this who manages their dry eye with eye drops, please do some reading or see a specialist. If all you do is use eye drops, your dry eye will likely get worse.
Eye drops bolster your tear film and help prevent desiccating stress to the eye surface, but they lack growth factors and other important compounds found in biological tears, and can even contribute to washing those away.
Last, whatever you do, don't use eye drops with preservatives (e.g. benzalkonium chloride).
Good advice to check, of course, but my friend that has chronic dry eye from Lasik was basically told it's a lifetime of drops for her now.
In the case above, I'm referring to my spouse. Her entire family has this problem - dry eye, frequent / continuous corneal erosions - setting in by their mid-late thirties. These are the people who end up wearing sleeping goggles, ointment, taping their lids shut, etc. It's not a lack of tear production, it's poor corneal basement layer adhesion for some undiagnosed reason and, probably, eyelids drifting open during sleep.
See this https://www.reddit.com/r/lasik/comments/cfxewr/how_to_fix_dr...
So, nearly 50% had new symptoms at 3 months.
MY STORY: I was recently interested in Lasik because I could no longer wear contacts. I ran into Dr. Oz's expose video right away, and realized that since at least 2013 there was a constant local/national news cycle promoting the lasikcomplications.com group.
This freaked me out quite a bit.
I read many of the negative posts, not all, but a large number said something like "Dr's told me my cornea wasn't thick enough but I had the procedure anyway."
THE NUMBERS: Google very heavily features https://lasikcomplications.com/ and its FB page when you do any basic search, their FB group https://www.facebook.com/groups/LasikComplicationsFaceBookGr... page has 6,400 members.
In the U.S. ~9 million people have had Lasik, internationally it's 30 million. There FB group has effectively no membership, their FDA petition has less than 2k signers.
The site mentions suicide rate prominently, but the baseline suicide rate from https://afsp.org/about-suicide/suicide-statistics/ is 14.0 per 100,000, and it didn't seem like that rate was higher for people who got Lasik, it seemed lower really.
Ok, so I was confident that people with real complications have an outlet, and that outlet seems to be concentrated in this single group, so english world complaints should be pretty reliably represented in this group... and there just aren't that many complaints.
so...... statistically outcomes look great.
RESULT:
I got Lasik 4 months ago, couldn't be happier with the outcome, due to my risk tolerances if I could have kept wearing contacts I wouldn't have gotten it but everything has been hunky dory. On the plus side because I can easily wear sunglasses again my light triggered migraines (transitioning to sunlight is a problem) have all but disappeared and I am back long distance cycling again because my vision isn't jostling on the bike any longer.
Also, this group definitely juices its numbers by focusing on the large percentage of people who have dry eyes and halos during the recovery period and they include those as "complications", I had those for the first month, I've since met a surprising number of people who got Lasik (they come out of the woodwork once you get it) and people have different lengths of recovery from dry eyes, the longest I've met was 7 months and they were still very happy with getting it.
Whether or not a third time would work, my laser surgeon already told me it would be the last time he'd try to fix it (which is a different tune than he was singing originally). Since my surgery, I've bumped into a number of other PRK patients who've had similar troubles.
Also, the procedure left me with "haloing", which means that when its dark outside and you see lights, they all have a white halo around them, which is super annoying.
Another word of warning to potential PRK patients: the recovery period for me was measured in weeks (over a month, for me), and during that time my vision was hampered enough to make it difficult or impossible to work on computer screen. All in all, I wish I never had PRK.
Completely satisfied 69.9% (151/216)
Very satisfied 22.7% (49/216)
Somewhat satisfied 4.2% (9/216)
Somewhat dissatisfied 0.9% (2/216)
Very dissatisfied 0.9% (2/216)
Completely dissatisfied 0.9% (2/216)
If the FDA guy concludes from this that the procedure should never have been approved, I'm tempted to say that it reveals more about the risk-averseness of the FDA than about the dangers of the procedure.
I've worn glasses since I was seven-years-old. They are a nuisance sometimes. But elective surgery, particularly for my eyes, makes me nervous. I don't want to take even a 1% chance of chronic eye problems to get rid of glasses.
A 1% chance of life-changing complications with something as critical as vision is, honestly, a shockingly high number for something I had assumed was far more safe.
The problem was never the surgery, it was the hype. I've regressed about 1 diopter over 15+ years, but that's better than being at 6 diopters and being almost unable to function without glasses.
In any event, taking away informed choice isn't what I want my taxes to pay the FDA to do.
I was 20/200 overall vision, and wore glasses since I was 11. At age 27, before going into law enforcement, I underwent the Lasik operation, and it was definitely a life changer.
Living near swamps, in the south, it wasnt uncommon to walk outside from an air conditioned building, and have your glasses instantly fog. My skin gets incredibly oily and the glasses would slide down my face. It was hard to find frames that didn't leave huge uncovered and distracting gaps in my peripheral vision from being too small.
In the academy, I saw plenty of guys have to deal with glasses falling off of their faces while doing pushups/working out. They'd have to evaluate "Do I want to see or do I want to not break my glasses" during defensive tactics training.
Post graduation, I can only imagine how negatively glasses would've impacted my job. Water getting on the lenses in the rain, splatter getting on them while tracking people through the woods. Sweat and condensation blocking your vision. This assumes they stay on.
Having to wrestle around with someone to get them into handcuffs is difficult enough, and its incredibly easy to get tunnel vision. Staying aware of your surroundings is important, and there would be a significant amount of due stress if you couldn't see what you were doing because your glasses got knocked into a ditch.
Also, some of the negative responses to such a survey can be avoided by proper screening of candidates and not just wanting to take the money of every person who walks in the door. For all we know, the people who responded negatively to that survey were never good candidates for lasik in the first place and are just frustrated they spent the money for little change in their vision.
This is only my own experience, but I'm quite certain that contacts are not a solution for everyone.
I had lasik when I was 30 (I think) I've been incredibly pleased with it.
But - frankly, your story is very difficult to relate to, and some of it sounds unreasonable. Oily skin cannot make glasses fall off your nose, unless they don't fit to being with; they're (supposed to be) supported by the structure of your ear and nose, not by static friction; you should have changed your frame.
Now, yes, they can fall off if you lean all the way forward; or if you throw your head around during physical activity. Or you don't want them to be at risk when playing soccer or volleyball or what-not. Well, you get prescription goggles for that; They're not that expensive.
I was really depressed and annoyed with having to wear glasses for a couple of months after I started to. Then, gradually, I forgot about them. That is, I didn't forget to wear them, I forgot about the hassle of wearing them. Yes, occasionally I get annoyed by raindrops, or a thumbprint, or having to tighten one of the screws. But it's really not as bad as you describe.
Caveat: My visual acuity without glasses is better than yours.
As we learn the dangers of things people start the arduous process of protesting them. See bpa, Teflon. Both got phased out after years and years of denials and lawsuits. Bpa and Teflon may have been mostly phased out, but they have been replaced by unknowns, which are reasonably expected to be about as bad as their predecessors.
Rather, I think the stakes for equivalently sized day to day risks are getting bigger because lives are getting more complicated, and bad bets can snowball a lot easier now.
Want to see risk? Take a good long hard look at the speculative and corporatedebt markets. hardly a risk adverse market.
Teflon (PTFE) and BPA are nowhere close to being phased out. Every single metal can in America is lined with BPA, and there is pretty much nothing that used to use PTFE that has stopped using it.
https://www.packagingdigest.com/food-packaging/most-food-can...
Aluminum cans (beverages) have not replaced BPA yet. Here is more info https://cen.acs.org/business/consumer-products/new-epoxy-boo...
I wouldn't be surprised at all if actually those are from cheap doctors.
For example, you could say, “I’d like to think these failures are a result of lack of skill or experience on the part or the doctor, careless errors, or perhaps poorly maintained tools/equipment, and not a fundamental issue with the procedure itself which could effect even skilled and diligent practitioners. I wonder if the study accounted for the experience level of the practitioner?”
>I wouldn't be surprised at all if actually those are from cheap doctors.
Even if this was completely true, the ease or difficulty of a medical treatment is a fundamental part of that treatment. If a treatment is simply incredibly hard for humans to perform effectively and carries risk of significant irreversible damage, that is a very different treatment in practice than one that is trivial and/or with minimal/temporary downsides even if it goes wrong. It's like with medicines themselves, where there is the concept of a "therapeutic index", the ratio between the minimum effective dose and a lethal dose. Some medicines have wide indexes, up to the point where it's essentially impossible to overdose (raw matter effects would hit first). These are fine to just have offered OTC for self-medication. Others, including very valuable ones, can have extremely narrow windows and thus require specialist prescription and ongoing monitoring/adjustment, up to and including only for use in a hospital.
Allowing "cheap" (inexperienced? unskilled? incorrect training?) practitioners to perform LASIK was itself a medical choice. Current training/licensing regimes are an inextricable part of the LASIK procedure, and if in practice there have been significant adverse results that should still be reviewed. It wouldn't have to mean banning the procedure entirely, but if it's a lot more dangerous than originally assessed the how|who|where of its performance might need refinement. "Caveat emptor lol" isn't how a good medical system is run.
After LASIK my wife complained for months about seeing a halo around street lights at night time, until I convinced her, that with my then nearly perfect vision I also see them depending on how tired I am.
Before that she believed they were caused by the surgery, so might have responded "slightly dissatisfied" on the survey.
She probably never saw the halos before it, because her vision would simply blur them out together with everything else. Or simply never paid attention.
Disclaimer, I'm a fat guy and t2d, this is practical not meant to be offensive.
This doesn't mean the procedure shouldn't have been approved, it most likely means that folks need to do better patient education and qualification. Not everyone needs to be a good candidate.
It's also possible that these results vary a lot between LASIK docs. I'd expect that some qualify patients more thoroughly than others. Risk for developing side effects can be assessed beforehand, to some extent.
"Results A total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%)."
I would really like someone to explaine these figures to me:
https://cdn.jamanetwork.com/ama/content_public/journal/ophth...
E.g. for dry eye, from PROWL-1 [2], table 2: before: 45% any severity, 6% severe; after 6 months: 27% any severity, 3% severe; and those changes included 19.5% of those without symptoms developing new symptoms and 65% of those with prior symptoms seeing those resolve.
But it's really hard to interpret the data because a surprisingly large fraction of people report changes (both no symptoms to symptoms and vice versa) over some period of time without having lasik at all! ("14% (95% CI, 3%-35%) to 29% (95% CI, 13%-49%) of participants answered that they either did or did not have a symptom on the test and vice versa on the retest")
See my comment [1] for more.
[1] https://news.ycombinator.com/item?id=21547710
[2] https://jamanetwork.com/journals/jamaophthalmology/fullartic...
If this was a life-saving procedure with a 50/50 chance of working with no alternatives, then that's different. But an elective procedure where a perfectly healthy person sees an advertisement one day, and has their life ruined the next is not something that should be acceptable.
So the choice was either rubberstamp it so there was oversight or don't and potentially have even worse cases.
The people who get LASIK chose to do it either because they saw an advertisement or someone convinced them to do it. Nobody's life is saved by LASIK, and people can live a perfectly good life without it. They can wear glasses or contact lenses, or wait until someone comes up with a safe alternative to LASIK.
Read through some of the stories [1] from people who have had complications so you see that this isn't a minor statistic that can be easily ignored. Peoples lives are actually being ruined.
I hear Lasik ads regularly. They never/rarely mention side effects. Just "hey, come get Lasik and see better!"
I never hear ads for boob jobs, nose jobs, or lipo.
And medication ads are always ended with a listing of side effects. "Complications include bleeding, puking, bloat, pimples, and death."
If commercials for LASIK were like drug commercials ("... side effects include vomiting, migraines, and death..."), we'd likely have a more informed populace.
Or, you could stick with your reliable car that has some scratches and dents and needs a quart of oil when you fill up.
The LASIK procedure is just utterly insane in comparison, especially given its extremely limited advantages.
The staff and doctor all tried mightily to get me to do LASIK, and after I refused multiple times, every staff member confessed that they either did or would have made the same choice.
IIRC, from my research, dry eyes are more common with Lasik than PRK. But you make a good point: PRK isn't side-effect free, either.
The way I see it, my vision was really bad before LASIK. It got perfect with LASIK. Yes, it might degrade a bit with time, but definitely not even close to the level it was before. So either way, I am ending up in a better spot that I started from.
Also, additional therapies aren't completely ruled out. The clinic I got it at provides lifetime corrections for free, if I end up needing it in the future.
The argument years ago that convinced me NOT to have this procedure done was that they'd have to remove fully half my cornea. I'm assuming there are ways to recover from that with a corneal transplant, but that's a big risk and a lot of resources consumed just for the sake of not wanting to wear glasses.
Flash forward fifteen years and I'm diagnosed with early onset cataracts. Turns out they can pick a lens implant that corrects out the distortion caused by the shape of the eyeball. That was the procedure that got me to where I didn't need glasses, even though that wasn't remotely close to the primary motivation.
https://www.npr.org/sections/health-shots/2015/05/21/4065023...
Also, how would you rate your personal pain and discomfort tolerance?
My older bother started them at the same time as me, and he couldn't handle it, so he swapped back to glasses after a few years.
Apparently I don't have enough corneal tissue, which resulted in poor and increasingly bad vision starting every day around 3pm (~9 hours after removing lenses). My pupils also dilate surprisingly large, with no lenses being able to pull tissue over the entire dilated pupil, resulting in super nasty halos around light sources. The halos alone were bad enough that I wouldn't have been able to safely drive at night.
I am glad, though, that the attempt was completely, 100% side-effect free (except for my wallet). After a day or two, my vision returned to its terrible origin, with no halos or discomfort or anything.
The results were remarkable but the contacts themselves where insanely uncomfortable.
But after reading the article, I don't know how much weight there is to this. Seems to be a small sample and that report is heavily highlighting a couple negative items out of a largely happy pool of patients.
Was there any connection to the doctor or clinic? Did some clinics or equipment have a higher rate of complications? I'm getting mine performed at a well reviewed practice in San Jose.
This article isn't enough for me to cancel the procedure, but it was enough of a scare to put me on the edge for a second. Sensationalism? Maybe not quite, but it'd be great if these reports would work to remove their bias.
In each of the PROWL studies, less than 1 percent of patients experienced difficulty performing their usual activities following LASIK surgery due to any one symptom.
...
* Up to 46 percent of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.
* Participants who developed new visual symptoms after surgery, most often developed halos. Up to 40 percent of participants with no halos before LASIK had halos three months following surgery.
* Up to 28 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. This is consistent with previous studies.
* Less than 1 percent of study participants experienced "a lot of difficulty" with or inability to do usual activities without corrective lenses because of any one visual symptom (starbursts, ghosting, halos, glare) after LASIK surgery.
* More than 95% of participants were satisfied with their vision following LASIK surgery. Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider
https://www.fda.gov/medical-devices/lasik/lasik-quality-life...
LASIK in the 90s involved physically cutting the surface of the eye with a keratome (blade) and relied on the precision of the surgeon's hand.
The procedure itself was as comfortable as they could make it, you know, for cutting a flap in your eye and blasting part of it away.
This morning I went in for followup and have 20/15 vision. A mild amount of blood under one flap which will dissipate within a week.
So far, only mild discomfort after the initial healing yesterday, which was pretty irritating. Now, it just feels like there's an eyelash that won't go away. I have to keep reminding myself that I can't adjust my contact lenses any more.
There is some staring I noticed looking at the clock display in a dark room, but nothing worse than the old pair of glasses I was wearing in the interim. But that's supposed to almost completely fade over 6 months.
I know that, "time will tell", but thus far, I'm very optimistic. I'd definitely recommend this doctor to anyone.
I filed that one away.
Watching my sister, who had it done ~10 years ago, struggle to stay between the lines on the freeway at night due to halos I wrote it off completely. Even with these issues she’s perfectly happy with the results. Again, I don’t get it.
I was myopic (20/350) that got corrected to 20/15. Things I can do now: * Being able to lay in bed and look around the room and see things in focus. * Being able to lay in bed and look at my significant other and it not be a out-of-focus blurry mess. * Being able to get up in the middle of the night to go to the bathroom without hunting for glasses. * Being able to go swimming without goggles. * Avoiding the discomfort of contact lens wear and cleaning. * Being able to do read while laying on the couch without bending my frames. * Avoiding possibility of eye infection due to dirty contact lenses. * Avoiding the need to clean and wash glasses due to dirt. * Avoiding the painful removal of contact lenses after falling asleep with them in due to tiredness.
etc, etc etc
In my sisters case, she now has prescription night driving glasses and prefers not to drive at night with my niece. I’m not sure why but “was worth it” is what she’d say and similar reasons to yours are what she’d give.
If it's just a slight convenience then yeah... keep that stuff away from me.
(BTW, I am nearly blind without my glasses, but that's never really bothered me. I just wear the glasses.)
They calculated in 1/2000 lifetime chance of vision loss from contacts vs a 1/10000 chance for refractive surgery.
After experiencing truly dry eyes for the first time - from contact lenses - I will probably never get laser correction. Even a 1% chance of having permanent dry eyes at that level of discomfort sounds horrific.
Also, the slight chance of losing near vision in exchange for far vision is not worth it imo. I'd like to put off needing glasses to read in bed for a few more decades.
I can still read fine print etc, however.
I take my glasses off to read up close; I can't make out faces across a room without them, but at close range they actually make things blurrier. Contacts kill it, too, which is why I didn't use them for long. I've been thinking of getting a pair just for using in VR, since my glasses don't fit well, but I dunno.
I’m pretty sure it’s a small percentage of people in the Navy.
I think it is unfair to blame suicides on the procedure, as they warn you about the risks beforehand and are clear that you may have some halos/blurriness for a few months.
Blame the suicide on mental illness, because that is where the problem actually lies. Anything else seems like an emotional play to get money from a lawsuit.
Also if you do the math it can potentially save you money on contacts and the ever-obnoxious eye checkups.
9 years since I had it done and it is amazing. No regrets so far.
I get out of bed every day and I can just see. No searching for glasses or going to the bathroom to put contacts in.
https://www.rx-safety.com/product-category/master-safety-gla...
(Apparently my "parameters" are such that I'm in a gray area where some surgeons will perform LASIK, but others won't. My prescription is pretty high in one eye (around -8). I ended up not being a great candidate for any corrective eye surgery, intraocular lenses included.)
Anyway, intraocular lenses are definitely more invasive, but from what I recall they sounded like a better option to me than LASIK in general: apparently vision quality is better than LASIK with IOLs, there's no removal of corneal tissue, and chance for complications was lessened. (Well, as I understood it, there were fewer minor complications, but more possible major complications, which is maybe not a trade-off many people want to make.)
Of course, they cost about 2x as much as LASIK.
I'm pretty sure they are FDA approved, especially given their use in cataract surgery, although the ones in cataract surgery replace the natural lens whereas the corrective type typically do not...
Also, if you're that old, it might mean an instant need for reading glasses (if you don't already have them).
Being nearsighed is like permanently wearing a pair of reading glasses. Given how much of my day is taken up reading vs. using distance vision, part of me regrets getting my eyes corrected to 20:20.
But from what I see in the article, the negative experiences are few and far between, not to mention, they don't seem to take into account variation between different clinics. Is there a connection in quality to the doctor or their practice? Is there some problem with a piece of equipment?
My suggestion would be, if you're thinking of doing it, make sure the eye doctor who checks out your candidacy is one you trust and hopefully have been with for a while. When it comes down to it, the procedure itself is pretty safe and automated so the part to optimize is screening people before the procedure happens.
Now many years afterwards, the only thing I see clearly is that I should never have gotten the surgery.
Both eyes continued to have changes in prescription, and I now wear contacts in both eyes.
By the numbers, it would seem like I have pretty good vision. Corrected I have 20/20 in my non-surgery eye and 20/25 in the eye that had the surgery.
HOWEVER - the non-surgery eye focuses quickly and accurately, even in low light and at night. The surgery eye can read the eyechart as well, but it takes longer, I have to blink and wait and maybe... eventually... I can read the 20/25 line. At night, I get visual artifacts.
I recommend good contacts instead. Your vision will change and you can just get different contacts.
Additionally, contact lenses have advanced. They can now correct almost any level of vision including astigmatism and can be thrown away monthly or even more frequently.
Why did she get LASIK? When I got it, it was made extremely clear that it wouldn't help with reading glasses-level problems and may in fact cause me to need them.
It's a very successful procedure, for the vast majority of people who undergo it. I fail to see why "it should never have been approved".
WTF would you get eye surgery if you don't need glasses to begin with!?
I wear glasses every day as I can't seem to read and focus properly using contact lenses (tried about 5-6 times the last 15 years) and the quality is great. I use those high index glasses that are so thin you'd think they are -3.
I still think about some kind of surgery though - maybe ICL ?
ANYONE who gets both eyes done at once has no baseline to compare against.
I can compare.
The great advantage to engineers/craftspersons of not getting LASIK if you are short sighted, is that you can take out your contact lenses for close/fine work.
The eye with LASIK is useful for swimming, travelling, and convenience of not using contacts (which sometimes irritate).
Other kinds of surgeries have longer recovery times, so they're kinda forced to do them one eye at at time.
However, I also notice that better results are reported for later surgeries, over e.g. five years.
Now, >15 years later, I still have 20/13 vision in both eyes, from a starting point > 20/100.
It’s fantastic and greatly improved my quality of life.
Unfortunately, as far as I could tell, there aren't very good studies on the topic - they're very limited in number of people and in length of time studied, or they don't measure a control group/baseline - which is a big problem because there is a surprisingly high prevalence of symptoms in the population even before lasik. This makes the data very hard to interpret.
E.g. [1] reports that 6 months after surgery, "41 percent of patients reported visual aberrations, with nearly 2 percent saying the symptoms presented 'a lot of difficulty' or 'so much difficulty that I can no longer do some of my usual activities.' But looking at the data from the PROWL-1 and PROWL-2 studies [2], table 3, 67% of patients had some visual symptom _before_ lasik surgery, with 3.3% / 7.5% having difficulty performing activities and 10.8% / 13.3% reporting "very" or "extremely" bothersome symptoms (again, before lasik). The prevalence of severe visual symptoms decreases 6 months after lasik. However, while some people go from severe symptoms to no symptoms, some of that is just due to regression to the mean (see note on test-retest in [2]), and there is also a substantial percentage of the population that goes from no symptoms to having some symptoms (which is the main thing I am trying to estimate).
Surveying some of the other literature [2][3][4], the overall pattern I saw was that pre-lasik the prevalence of dry eye and visual symptoms is about 60% of any severity, 5% severe, 5-10% moderate. Post-lasik they are about 50% any severity, 3% severe, 5% moderate. Overall they are less postop - but the question is how many people who were normal preop develop symptoms postop (minus how many people who were normal develop symptoms 6 months later without any lasik surgery). I haven't found good enough data to answer this with any degree of accuracy, other than an upper bound of <1% developing severe symptoms and <5% developing moderate symptoms. That isn't a very helpful upper bound to me - a 1% chance of permanent severe complications is a lot, and I think it's obvious that if the rate were that high we'd know about it. But from the data it appears plausible that the rate of developing long-lasting moderate complications is 0.1% - 1%, and the high end of that range is still a pretty substantial rate of complications. I think the actual rates are a lot lower, we just don't seem to have enough data to measure it better. I would love to see pointers to better studies, better analyses of the data, etc.
[1] https://www.nytimes.com/2018/06/11/well/lasik-complications-...
[2] https://jamanetwork.com/journals/jamaophthalmology/fullartic...
Didn't read the article...
There have also been a number of co-workers and distant friends who suddenly stopped wearing glasses, and seem quite happy with their Lasik.