6 ms·

So in the study the article refers to, when asked after 6 months "Currently, how satisfied or dissatisfied are you with the result of your LASIK surgery?" on a

So in the study the article refers to, when asked after 6 months "Currently, how satisfied or dissatisfied are you with the result of your LASIK surgery?" on a 6-point scale, the responses were: 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) (this is from eTable 4 in the supplement here: https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2587831 https://jamanetwork.com/journals/jamaophthalmology/fullartic...). 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.

jmwilson 7y ago
The FDA's mandate is to ensure safe and effective therapies, not high customer satisfaction.
Freak_NL 7y ago
Three percent dissatisfaction and another four percent merely ‘meh’ is pretty high for an elective, perhaps even cosmetic, procedure that operates on something as fragile and irreplaceable as the eye.
- scott_s 7y ago
  This is an important perspective. If these were the rates for a necessary medical intervention, we would be ecstatic. Because for a necessary medical intervention, the patient's baseline is not good. But wearing glasses is mostly a nuisance, not a health issue. 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.
  - hsitz 7y ago
    Well, I would say we'd also need a little more information about the 'dissatisfied' responses. It could be that none of them worsened the person's eyesight, they were just dissatisfied with the level of improvement, or that they still needed corrective lenses after the lasik. Or maybe not, but hard to tell simply from those poll questions, many people have unrealistic expectations.
    - scott_s 7y ago
      Anecdotally, I know two people who had minor complications (chronic dry eye; sensitivity to light), but enough that they regretted the procedure. I also know more people who are very happy with it. But that's enough to dissuade me.
  - joeraut 7y ago
    I'm in the same situation as you. Worn glasses/contact lenses from a young age. 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.
  - nkrisc 7y ago
    I wear glasses as well. I've considered laser eye surgery. But I've decided against it, and all it took was learning about some of the bad outcomes. It's just not worth the risk. My eyesight is not that bad and glasses are fine. With my vision, 1 in 10 chance of being unsatisfied is not worth it. Sure, 9 of 10 times I'm happy, but I would far unhappier with a negative outcome for something so unnecessary than I would be happy with a good outcome.
  - CamperBob2 7y ago
    Right now you have chronic eye problems, in the form of a lack of focusing ability. When I underwent LASIK, I knew my eyes weren't perfect before it, and that they wouldn't be perfect afterward, either. 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.
- MFogleman 7y ago
  I understand the 'cosmetic' argument, and would like to offer my personal experiences as a counter. 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.
  - sjg007 7y ago
    Ok but what about contacts?
    - obmelvin 7y ago
      Improper use of contacts can scratch ones eyes and not everyone can comfortably wear contacts. The risk of LASIK may not appeal to some, but saying "what about glasses or contacts?" is a silly question from the perspective of someone who has had LASIK. It's a personal choice. 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.
    - SapporoChris 7y ago
AWildC182 7y ago
We're becoming an incredibly risk averse society. Not sure what that means for the future...
- Red_Leaves_Flyy 7y ago
  I don't think society is becoming more risk averse. We still do a ton of drugs, drink, drive, fly, fight and commit crimes. 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.
  - hammock 7y ago
    >See bpa, Teflon. Both got phased out 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.
    - maxerickson 7y ago
      Are you in the canned food industry? https://www.packagingdigest.com/food-packaging/most-food-cans-no-longer-use-bpa-in-their-linings-2018-02-20 https://www.packagingdigest.com/food-packaging/most-food-can...
      - hammock 7y ago
        That is steel cans (food) and good info. However I am curious what they are using to bond the acrylic or polyester lining to the can. Aluminum cans (beverages) have not replaced BPA yet. Here is more info https://cen.acs.org/business/consumer-products/new-epoxy-boot-BPA-cans/97/i10 https://cen.acs.org/business/consumer-products/new-epoxy-boo...
aiyodev 7y ago
Even a 1% failure rate is extremely high. This is incredibly bad.
- martin_ 7y ago
  The results do not suggest failure, there are many other explanations for such results. The patient may have expected better vision than they have (eg 20/20 but wanted 20/15), or their prescription wasn't stable so vision deteriorated slightly after 6 months.
  - vilhelm_s 7y ago
    The study had 8 people where the surgery caused "very" or "extremely" bothersome visual problems, and 4 people reporting difficulty performing activities due to these; I guess those are included in the 6 dissatisfied people.
    - vokep 7y ago
      Is there any info on where they got the procedure? From what I understand, LASIK is quite reasonably safe, as long as you don't goto a place advertising "SUPER SUPER CHEAP LASIK ONE EYE FREE" etc. You get what you pay for. I wouldn't be surprised at all if actually those are from cheap doctors.
      - tracker1 7y ago
        It's not so much the cost, as the amount of experience a given doctor has. You may be surprised to find that some of the cheaper options are safer because of the increased experience. Skill is an entirely different factor to consider, again not associated with pricing.
      - zaroth 7y ago
        Speculating like this is useless and generally counterproductive. It’s just a way of stating your internal biases, it’s best to recognize that bias and consider how that impacts your perception. 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?”
maxkwallace 7y ago
Thanks for pulling out the data! One problem is that "somewhat", "very", "completely" don't give a good picture of how dissatisfied these 2.7% of patients are. It's possible some of them developed serious dry eye which can be totally debilitating. 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.
ars 7y ago
216 responses is not enough to gain data on the few people who were dissatisfied.
mcguire 7y ago
From that study: "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/935943/eoi160091f1.png?Expires=2147483647&Signature=O7xcHM6XLfqIipdg~wDhYUJT5VHabNmtHsF0rjFJ~KE7ik6tp0pA36XBzBPzMzh0-CcW8Xwb-EuHpK-fgpabClQhMIM4H2bhRuIf4WY-KXgXS-xsCpqhZQVB72AIRqD186AwFo9ODPakHHt4mfe8b9uqNKNIjVh~yzSsPDF8-hXeg675g3ydeidMz6nMbs0kah6LOVNHKiAxoNqs7hZvl0DE3yW1MZCF56QGBWEYthwxKtgMO6iQ7wFXmdLdhkZiTf-eT7Ef2JOS33Tuq9AtYy0kPlpSTopTotvN-Nv5-2ISCATcKXtrq1OR5nU4uuZOq8dLxTN0h9On9d4YWH5~Sw__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA https://cdn.jamanetwork.com/ama/content_public/journal/ophth...
- jchen5 7y ago
  The data says a lot of people have mild/moderate visual visual artifacts (halos, starbursts, etc.) and dry eye prior to getting lasik. Lasik appears to make some of those symptoms disappear in many people, but also causes symptoms to appear in a smaller number of people. 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 https://news.ycombinator.com/item?id=21547710 [2] https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2587831 https://jamanetwork.com/journals/jamaophthalmology/fullartic...
bogwog 7y ago
This is a dangerous perspective on the issue. Why should the FDA approve an elective procedure that has the possibility of ruining your life? Lots of perfectly healthy people people who had a bad outcome have committed suicide due to the unbearable pain and suffering. 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.
- zionic 7y ago
  It's entirely acceptable on a society level if the numbers are low enough. If 1 in a billion die from a vaccine, do you approve it? There's probably at least one person who died in an accident from an airbag that otherwise wouldn't have without an airbag. Do we remove airbags despite them being statistically safer? This kind of "Zero Allowable Risk" attitude is quite frankly technophobic.
  - madamelic 7y ago
    Not only is it a measurement of how many lives will be improved, it was a stopgap on non-regulated procedures. So the choice was either rubberstamp it so there was oversight or don't and potentially have even worse cases.
  - bogwog 7y ago
    None of those examples you gave work here. The numbers that die from vaccines are much lower than the numbers that die without them, and it's a problem where a decision must be made. And nobody chooses or is convinced to be in a car accident. Shit just happens. 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. [1] https://www.lasikcomplications.com/letters.htm https://www.lasikcomplications.com/letters.htm
ebiester 7y ago
Isn't the real question "how satisfied are you after a decade" when discussing the claims in the article?
- einpoklum 7y ago
  After a decade you might just be too used to whatever it is you did a decade ago...
tomohawk 7y ago
This is like buying a car that has a .9% chance of conking out on the side of the road, a .9% chance of colliding with another vehicle with no injuries, and a .9% chance of blowing up when you turn the key. Or, you could stick with your reliable car that has some scratches and dents and needs a quart of oil when you fill up.
lern_too_spel 7y ago
The suicides aren't going to take the survey, which skews the survey results in a favorable direction but are of interest to the FDA.

jmwilson 7y ago

The FDA's mandate is to ensure safe and effective therapies, not high customer satisfaction.

Freak_NL 7y ago

Three percent dissatisfaction and another four percent merely ‘meh’ is pretty high for an elective, perhaps even cosmetic, procedure that operates on something as fragile and irreplaceable as the eye.

scott_s 7y ago
This is an important perspective. If these were the rates for a necessary medical intervention, we would be ecstatic. Because for a necessary medical intervention, the patient's baseline is not good. But wearing glasses is mostly a nuisance, not a health issue. 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.
- hsitz 7y ago
  Well, I would say we'd also need a little more information about the 'dissatisfied' responses. It could be that none of them worsened the person's eyesight, they were just dissatisfied with the level of improvement, or that they still needed corrective lenses after the lasik. Or maybe not, but hard to tell simply from those poll questions, many people have unrealistic expectations.
  - scott_s 7y ago
    Anecdotally, I know two people who had minor complications (chronic dry eye; sensitivity to light), but enough that they regretted the procedure. I also know more people who are very happy with it. But that's enough to dissuade me.
- joeraut 7y ago
  I'm in the same situation as you. Worn glasses/contact lenses from a young age. 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.
- nkrisc 7y ago
  I wear glasses as well. I've considered laser eye surgery. But I've decided against it, and all it took was learning about some of the bad outcomes. It's just not worth the risk. My eyesight is not that bad and glasses are fine. With my vision, 1 in 10 chance of being unsatisfied is not worth it. Sure, 9 of 10 times I'm happy, but I would far unhappier with a negative outcome for something so unnecessary than I would be happy with a good outcome.
- CamperBob2 7y ago
  Right now you have chronic eye problems, in the form of a lack of focusing ability. When I underwent LASIK, I knew my eyes weren't perfect before it, and that they wouldn't be perfect afterward, either. 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.
MFogleman 7y ago
I understand the 'cosmetic' argument, and would like to offer my personal experiences as a counter. 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.
- sjg007 7y ago
  Ok but what about contacts?
  - obmelvin 7y ago
    Improper use of contacts can scratch ones eyes and not everyone can comfortably wear contacts. The risk of LASIK may not appeal to some, but saying "what about glasses or contacts?" is a silly question from the perspective of someone who has had LASIK. It's a personal choice. 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.
  - SapporoChris 7y ago

AWildC182 7y ago

We're becoming an incredibly risk averse society. Not sure what that means for the future...

Red_Leaves_Flyy 7y ago
I don't think society is becoming more risk averse. We still do a ton of drugs, drink, drive, fly, fight and commit crimes. 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.
- hammock 7y ago
  >See bpa, Teflon. Both got phased out 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.
  - maxerickson 7y ago
    Are you in the canned food industry? https://www.packagingdigest.com/food-packaging/most-food-cans-no-longer-use-bpa-in-their-linings-2018-02-20 https://www.packagingdigest.com/food-packaging/most-food-can...
    - hammock 7y ago
      That is steel cans (food) and good info. However I am curious what they are using to bond the acrylic or polyester lining to the can. Aluminum cans (beverages) have not replaced BPA yet. Here is more info https://cen.acs.org/business/consumer-products/new-epoxy-boot-BPA-cans/97/i10 https://cen.acs.org/business/consumer-products/new-epoxy-boo...

aiyodev 7y ago

Even a 1% failure rate is extremely high. This is incredibly bad.

martin_ 7y ago
The results do not suggest failure, there are many other explanations for such results. The patient may have expected better vision than they have (eg 20/20 but wanted 20/15), or their prescription wasn't stable so vision deteriorated slightly after 6 months.
- vilhelm_s 7y ago
  The study had 8 people where the surgery caused "very" or "extremely" bothersome visual problems, and 4 people reporting difficulty performing activities due to these; I guess those are included in the 6 dissatisfied people.
  - vokep 7y ago
    Is there any info on where they got the procedure? From what I understand, LASIK is quite reasonably safe, as long as you don't goto a place advertising "SUPER SUPER CHEAP LASIK ONE EYE FREE" etc. You get what you pay for. I wouldn't be surprised at all if actually those are from cheap doctors.
    - tracker1 7y ago
      It's not so much the cost, as the amount of experience a given doctor has. You may be surprised to find that some of the cheaper options are safer because of the increased experience. Skill is an entirely different factor to consider, again not associated with pricing.
    - zaroth 7y ago
      Speculating like this is useless and generally counterproductive. It’s just a way of stating your internal biases, it’s best to recognize that bias and consider how that impacts your perception. 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?”

maxkwallace 7y ago

Thanks for pulling out the data! One problem is that "somewhat", "very", "completely" don't give a good picture of how dissatisfied these 2.7% of patients are. It's possible some of them developed serious dry eye which can be totally debilitating. 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.

ars 7y ago

216 responses is not enough to gain data on the few people who were dissatisfied.

mcguire 7y ago

From that study: "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/935943/eoi160091f1.png?Expires=2147483647&Signature=O7xcHM6XLfqIipdg~wDhYUJT5VHabNmtHsF0rjFJ~KE7ik6tp0pA36XBzBPzMzh0-CcW8Xwb-EuHpK-fgpabClQhMIM4H2bhRuIf4WY-KXgXS-xsCpqhZQVB72AIRqD186AwFo9ODPakHHt4mfe8b9uqNKNIjVh~yzSsPDF8-hXeg675g3ydeidMz6nMbs0kah6LOVNHKiAxoNqs7hZvl0DE3yW1MZCF56QGBWEYthwxKtgMO6iQ7wFXmdLdhkZiTf-eT7Ef2JOS33Tuq9AtYy0kPlpSTopTotvN-Nv5-2ISCATcKXtrq1OR5nU4uuZOq8dLxTN0h9On9d4YWH5~Sw__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA https://cdn.jamanetwork.com/ama/content_public/journal/ophth...

jchen5 7y ago
The data says a lot of people have mild/moderate visual visual artifacts (halos, starbursts, etc.) and dry eye prior to getting lasik. Lasik appears to make some of those symptoms disappear in many people, but also causes symptoms to appear in a smaller number of people. 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 https://news.ycombinator.com/item?id=21547710 [2] https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2587831 https://jamanetwork.com/journals/jamaophthalmology/fullartic...

bogwog 7y ago

This is a dangerous perspective on the issue. Why should the FDA approve an elective procedure that has the possibility of ruining your life? Lots of perfectly healthy people people who had a bad outcome have committed suicide due to the unbearable pain and suffering. 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.

zionic 7y ago
It's entirely acceptable on a society level if the numbers are low enough. If 1 in a billion die from a vaccine, do you approve it? There's probably at least one person who died in an accident from an airbag that otherwise wouldn't have without an airbag. Do we remove airbags despite them being statistically safer? This kind of "Zero Allowable Risk" attitude is quite frankly technophobic.
- madamelic 7y ago
  Not only is it a measurement of how many lives will be improved, it was a stopgap on non-regulated procedures. So the choice was either rubberstamp it so there was oversight or don't and potentially have even worse cases.
- bogwog 7y ago
  None of those examples you gave work here. The numbers that die from vaccines are much lower than the numbers that die without them, and it's a problem where a decision must be made. And nobody chooses or is convinced to be in a car accident. Shit just happens. 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. [1] https://www.lasikcomplications.com/letters.htm https://www.lasikcomplications.com/letters.htm

ebiester 7y ago

Isn't the real question "how satisfied are you after a decade" when discussing the claims in the article?

einpoklum 7y ago
After a decade you might just be too used to whatever it is you did a decade ago...

tomohawk 7y ago

This is like buying a car that has a .9% chance of conking out on the side of the road, a .9% chance of colliding with another vehicle with no injuries, and a .9% chance of blowing up when you turn the key. Or, you could stick with your reliable car that has some scratches and dents and needs a quart of oil when you fill up.

lern_too_spel 7y ago

The suicides aren't going to take the survey, which skews the survey results in a favorable direction but are of interest to the FDA.