The Evidence that LASIK Makes Healthy Eyes Sick

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The Evidence that LASIK Makes Healthy Eyes Sick: The Impact on Public Health

Morris Waxler, Ph.D.
President, Waxler Regulatory Consultancy, LLC.
Former Branch Chief, Surgical Devices, FDA.

In this webinar, Dr. Waxler will discuss the impact that LASIK has on healthy corneas, and evaluate the latest research into the safety of the procedure.

Dr. Waxler will also propose a public health advisory on LASIK.


If you have any follow-up questions for Dr. Waxler, feel free to ask them in the thread below.

Note: ODwire.org's mission is education. If you have an alternative viewpoint about this or any other issue, contact us & we can arrange a webinar so you can get your position heard.
 
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AdminWolf

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I just reposted this ODwire.org Classic Webinar with a former FDA head -- the man who approved LASIK in the US.

If you have any questions or follow-ups, post 'em here, I bet we can get him to come back and update us on his progress...
 

AdminWolf

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I just reposted this ODwire.org Classic Webinar with a former FDA head -- the man who approved LASIK in the US.

If you have any questions or follow-ups, post 'em here, I bet we can get him to come back and update us on his progress...

Incidentally, we have a bunch of other classic webinars in the vault that we haven't reposted since ODwire.org's tech back-end was revamped in April.

I'm going to prioritize returning them back to the site based on the quality of their content. There's an awesome one on reading OCTs with Jerry Sherman that i'm getting back pronto.

thx
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AdminWolf

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Are the PDF's' still available?
It would really be interesting to hear his follow-up given any new data. Thanks for reposting.
I'll try to dig them up tonight, and maybe even drop morris a line to see what he's been up to the past couple of years!

stay tuned!
 

AdminWolf

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I'm confused, Adam. Since when are optometrists against LASIK? I thought everybody enjoys co-managing their happy LASIK patients.

For or against, not my problem! :)

This was a unique situation -- Waxler was the actual guy who was in charge at the FDA and pushed LASIK through back in the day.

Since he retired, he's had severe misgivings about the entire thing, and has based his subsequent work on trying to get the procedure scaled back. So I thought a show where he could air his feelings in front of educated folks would be interesting (normally he takes to the lay press to make his points.)
 

Greg Gemoules

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For or against, not my problem! :)

This was a unique situation -- Wexler was the actual guy who was in charge at the FDA and pushed LASIK through back in the day.

Since he retired, he's had severe misgivings about the entire thing, and has based his subsequent work on trying to get the procedure scaled back. So I thought a show where he could air his feelings in front of educated folks would be interesting (normally he takes to the lay press to make his points.)

I see, it's really about him and not about LASIK.
 

AdminWolf

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I see, it's really about him and not about LASIK.
Well no, it is about the data that he had at his disposal at the time vs. subsequent findings. listen to the show for a bit -- it is an interesting 'behind the scenes' describing how the sausage is made.

His motivations are ultimately something none of us can know.
 

Larry Bickford O.D.

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This is surely going to piss off LASIK lovers.

In my little nook of the optometric world, I see maybe 50 post LASIK folks annually. (I have a pretty small practice and see maybe 30 pts each week.) In the past year (approximate but good numbers), 40 of them had vision issues and only 10 were "happy", even though their BCVA was not necessarily all that great. Maybe 3 actually had pretty great vision and no problems at all. Youngsters, low myopes with thick corneas and an excellent operator.

The other 40: every single one was wearing specs all or part time. (Two ODs I know who were really happy at first are now wearing specs full time.) At least 5 were botched jobs with resultant BCVA 20/30 or less. At least half reported significant to disabling scotopic vision with acuity, contrast, flare and glare problems. Lots of dry eye issues. A friend has arranged his 35 mile carpool so that he doesn't drive after sunset, but is really happy to be able to surf without specs. Good for him, I guess. He's got few different specs for different occasions. Good for me, I guess, or not considering I pretty much gift him his vision aids.

The number of patients requesting consultation and referral for LASIK has plummeted from seemingly many each week a few years ago to maybe a dozen this entire year.

So that's 6% 20/20 or better, 20% botched, potentially life -altering poor outcomes, and 80% "happy". So my small sample is not much different than "advertised". IMHO, an elective procedure with an 80% success rate and a 10% failure rate is hard to recommend.

Obviously somewhere with a larger patient pool and with docs who carefully pick and choose good candidates and do the right thing, the real-life success numbers can be much better. And I trust that most of us are like that. But it just breaks my heart to be in the presence of patients who were perfectly happy with their specs/contacts and are now visually compromised and/or in denial.

But I sell a lot of Theratears, Systane, and multiple-pair AR specs, so who am I to complain? :p
 

AdminWolf

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This is surely going to piss off LASIK lovers.

In my little nook of the optometric world, I see maybe 50 post LASIK folks annually. (I have a pretty small practice and see maybe 30 pts each week.) In the past year (approximate but good numbers), 40 of them had vision issues and only 10 were "happy", even though their BCVA was not necessarily all that great. Maybe 3 actually had pretty great vision and no problems at all. Youngsters, low myopes with thick corneas and an excellent operator.

The other 40: every single one was wearing specs all or part time. (Two ODs I know who were really happy at first are now wearing specs full time.) At least 5 were botched jobs with resultant BCVA 20/30 or less. At least half reported significant to disabling scotopic vision with acuity, contrast, flare and glare problems. Lots of dry eye issues. A friend has arranged his 35 mile carpool so that he doesn't drive after sunset, but is really happy to be able to surf without specs. Good for him, I guess. He's got few different specs for different occasions. Good for me, I guess, or not considering I pretty much gift him his vision aids.

The number of patients requesting consultation and referral for LASIK has plummeted from seemingly many each week a few years ago to maybe a dozen this entire year.

So that's 6% 20/20 or better, 20% botched, potentially life -altering poor outcomes, and 80% "happy". So my small sample is not much different than "advertised". IMHO, an elective procedure with an 80% success rate and a 10% failure rate is hard to recommend.

Obviously somewhere with a larger patient pool and with docs who carefully pick and choose good candidates and do the right thing, the real-life success numbers can be much better. And I trust that most of us are like that. But it just breaks my heart to be in the presence of patients who were perfectly happy with their specs/contacts and are now visually compromised and/or in denial.

But I sell a lot of Theratears, Systane, and multiple-pair AR specs, so who am I to complain? :p

This sounds like a job for a Paul Farkas Survey -- of what people are actually seeing post-LASIK.
 

Jonathan Warner

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Adam,

Is there some way we could download that presentation to show to patients without logging onto ODwire to show them? I don't want patients trying to get on ODwire later.
 

AdminWolf

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Adam,

Is there some way we could download that presentation to show to patients without logging onto ODwire to show them? I don't want patients trying to get on ODwire later.

They'd have to lie there way in here and get past both me and Paul, (unlikely!)

but i'm transcoding the video and will have it on vimeo away from the site so you can point people there. should be done transcoding in a couple of hours

thx
adam
 

AdminWolf

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They'd have to lie there way in here and get past both me and Paul, (unlikely!)

but i'm transcoding the video and will have it on vimeo away from the site so you can point people there. should be done transcoding in a couple of hours

thx
adam

Video is here. should be ready for viewing any second:
 

Larry Bickford O.D.

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Thanks for making the Waxler presentation so easily available. It’s very cool that ODWire, and through your amazing IT skills and the hours of time spent has all of this kind of “professional development tools” for us to use. Knowledge is (supposed to be) power.

The fact that no one seems interested in discussing "the LASIK problem" speaks volumes. Are we going to be complicit in promoting a procedure that *might not* be in the best interest of our patients? Are we going to examine the data and prove, or disprove the safety and efficacy of refractive surgery?

Gotta go floss and get my teeth cleaned. Oh, wait...there's no data to support that frequent teeth cleaning has real-life benefits.

But thanks, Adam!
 

AdminWolf

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Thanks for making the Waxler presentation so easily available. It’s very cool that ODWire, and through your amazing IT skills and the hours of time spent has all of this kind of “professional development tools” for us to use. Knowledge is (supposed to be) power.

You're very welcome :)

I've got a bunch more of the old shows in 'the vault', if you think that there are any that might be appropriate for patients, I can host them off-site just like the LASIK one at a totally different address, just give me the word.

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Marc Provencher

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I discourage my patients from having LASIK, but the allure of spectacle free distance vision is great and I do refer patients, because, realistically, they will pursue it regardless, but at least my patients are informed about the risks.

It used to be that optometric referrals were important to LASIK surgeons/clinics, but now they all do direct marketing and optometric referrals are a small component.

I believe refractive surgeons are some of the most unethical medical practitioners. They advocated the original "slash for cash" RK, and look how well those patients are doing. Then came "flap and zap", a much safer procedure, but a significant percentage of patients have significant complications. The constant ads for LASIK with their "bait and switch" ($299 advertised), easy payment plans, we're doing a study, etc. I often wonder how they sleep at night. Then there are the hired guns: surgeons that fly in, do a hundred patients over the weekend at some LASIK Clinic, then fly out.

I actively discourage patients from having multifocal IOL's. The loss of contrast sensitivity, glare, and nearly doubling of the number of patients unable to drive at night is not acceptable to me. I refer patients for PE with IOL, and they return with a Restor. The surgeon has more sway than I do. Premium IOL's are a fantastic money maker, it pays considerably more than "baseline digital imaging" (sorry, couldn't help myself :)). Laser assisted cataract surgery is incrementally better, but it is another profit maker for OMD's.

Latisse anyone?
 

Michael Barris

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I had the opportunity to hear Svyatoslav N. Fyodorov, M.D., present his work on radial keratectomy in ophthalmology rounds at Mt. Sinai Medical Center in New York in 1980. The stylishly-dressed Dr. Fyodorov had made the trip from Moscow. His style was unusual for Soviet visitors.
 

Charles A McBride

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I discourage my patients from having LASIK, but the allure of spectacle free distance vision is great and I do refer patients, because, realistically, they will pursue it regardless, but at least my patients are informed about the risks.

It used to be that optometric referrals were important to LASIK surgeons/clinics, but now they all do direct marketing and optometric referrals are a small component.

I believe refractive surgeons are some of the most unethical medical practitioners. They advocated the original "slash for cash" RK, and look how well those patients are doing. Then came "flap and zap", a much safer procedure, but a significant percentage of patients have significant complications. The constant ads for LASIK with their "bait and switch" ($299 advertised), easy payment plans, we're doing a study, etc. I often wonder how they sleep at night. Then there are the hired guns: surgeons that fly in, do a hundred patients over the weekend at some LASIK Clinic, then fly out.

I actively discourage patients from having multifocal IOL's. The loss of contrast sensitivity, glare, and nearly doubling of the number of patients unable to drive at night is not acceptable to me. I refer patients for PE with IOL, and they return with a Restor. The surgeon has more sway than I do. Premium IOL's are a fantastic money maker, it pays considerably more than "baseline digital imaging" (sorry, couldn't help myself :)). Laser assisted cataract surgery is incrementally better, but it is another profit maker for OMD's.

Latisse anyone?

If I sent a patient for cataract surgery with a letter recommending a spherical, mono-focal IOL, and the patient came back with a multi-focal IOL, I would call the surgeon up to have a serious discussion, reserving the possibility of cursing.

I recently had a surgeon that I don't usually use try and talk a patient into a multi-focal IOL after I'd specifically counseled against it and in my letter to the surgeon, ahead of time, I went out of my way to mention to the surgeon that I'd discouraged its use. The surgeon tried recommending it anyway and ran into a problem because I'd recommended otherwise. It made the surgeon look bad and the patient unsure, who showed up at my office to discuss it and who had sensed what he'd felt was a sell tactic by the surgeon.

The optometrist and ophthalmologist need to be on the same page in regards to cataract surgery and the optometrist, who knows the case better than anybody, should be deferred to regarding the IOL recommendation, etc. -Charlie
 

Jerome Lietz

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From personal experience:
Starting from O.D. -6.00-1.00x60, O.S. -6.50-0.75x120...
O.D. done in Nov. 1999...still seeing 20/20- with occasional days slipping to 20/25 or 20/30 (rare)
O.S. done March 2000...at age 43, we deliberately left it at -1.25. Have NOT used reading assistance....EVER. Monovision worked!
No dry eye, no night vision complications. I guess I'm at the other end of Dr. Waxler's spectrum.
 
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Larry Bickford O.D.

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This week: female, 60-ish. 10-12 years post op. around -7 or 8 to start, one eye close to plano, now -.62ish, other eye was supposed to be -2.00 mono, now -4. BCVA 20/40- near eye corrected for dx, pinholes 20/25-), 20/25. Epithelial ingrowth, debris under flap. Pt uncomfortable driving (reports glare, halo-like blur, and near, really poor va in reduced light current PAL rx not working. HUGE amount of HOAs. Her Ks, BTW are down around 35D and distorted.

Surgeon told her it her cataracts. She does not have significant cataracts.

This represents another LASIK failure, IMO. And third one in two weeks to seek my help.
 
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Ryan Mckinnis

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Thanks It'd be great to hear other odwire docs that have had lasik chime in with their experience.

I had Lasik a little over a year ago. I was -5.50-0.75 X040 in my right eye and -6.00-1.50 X140 in my left eye. Still early in the grand scheme of things but I am 20/15 OD and 20/20 OS.
 

Greg Gemoules

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Few people have treated more LASIK regret patients than I have over the years. There certainly are problems with it as we all know. I am of the opinion that most of the cases I see now could have been avoided through proper patient selection. Most of them now are all young with very large pupils. They are very unhappy with the low light visual effects. Then there is the dry eye issue that is also very real, and these patients have to sit at a computer all day.

A recent scleral patient of mine just suffered a flap interface inflammation, i.e. sands of Sahara. I have had one other suspected case, but this is the first fresh case I have ever seen. This is something that usually occurs within days of the surgery, but can occur up to 12 years later (documented case). There was some kind of antecedent event in this case not involving the lens, but who knows?
 

Ron Redder

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I had LASIK about 12 years ago. I started at -1.75-1.00 with oblique cyl in both eyes. I am still 20/20 OU most of the time. Late in the day vision will drop a little if my eyes are dry. Still no presbyopia at 47 (yea:D).
 
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Marc Provencher

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Dr. Waxler stated in the video that the FDA's safety criteria for an elective procedure was a complication rate of 1% or less. You may quibble with his numbers and question "What is a complication", but it definitely is more than 1% for Lasik.

Consumer reports did a survey of 793 patients who had vision correction surgery since 2001. Results:
45% never had a side effect
53% reported initial side effects
12% had a second surgery to correct a problem
59% said they have no regrets
3% said they regret having had the surgery.

Among the main reasons for having surgery (respondents could cite more than one): 61% said they were tired of wearing glasses; 52% said they wanted to see a bedside clock in the morning; 38% said contact lenses were uncomfortable and hard to care for. But afterwards, 55% still needed to wear glasses or contacts at least sometimes. And of those who found it very hard to see that clock, just 36% had little or no trouble seeing it after surgery.

Consumer Reports further reported, "Although 80% of respondents said they were highly satisfied with the surgery, our findings point out the need for realistic expectations."

My 24 year old son with 3.5D of myopia and low cyl, wants Lasik. He has large pupils and really likes the 20/15 vision he has OD and OS with toric SCL. I'm not sure what to advise.
 

Tom Stickel

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I'm married to an MD who was a -3.00/-4.00 with K's around 39.50. Very difficult contact lens fit, hated glasses. I warned her off because of post op K issues but she had it done over 10 years ago.

Some loss of contrast sensitivity (faces of people in front of windows, etc.) but great VA, no dryness issues. She did get DLK the first week and had a flap lifted and rinsed, but everything has been great since then.
 

Alan David

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Mostly happy patients.
If they had dry eye issues before, they have them after LASIK.

Only unusual thing for me:
Have several that look like they have a permanent episcleritis going on.
Constant inflamed sector of conj.
I'm assuming the attachment of their conj tissue got compromised & is now permanently vascular.
Sending them back to surgeon usually result in palliative treatment (AT, plugs, Restasis).
I get the best response using my home-brewed diluted Alphagan-P.
 

Clarence Widmann

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ME:

Was approx -8.50 -2.00 wtr OU. LASIK w/ keratome in 2000. Was close enough to Plano OU to go without correction until 2007 ( 47 y/o ) when I added +1.50 readers.

*Bilateral PSC cataracts removed in 2012 replaced with SV aspheric Alcon IOLs set for distance OU. Now pl OD and +.50 -1.00 x 90 OS both 20/20 @ distance and interestingly J3 @ near.

I now hardly ever wear correction unless something is very small or it's very dark.


* My mother had bilateral PSC cataracts removed at age 48.
 

AdminWolf

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Another classic talk that I thought was worth bumping.

This gentleman was one of the main people involved in approving the LASIK procedure in the US. I was surprised that he agreed to give this talk with us, and even more surprised by his change of heart.

enjoy!
 
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This is an older thread, but I will bump it by saying I've seen around 20-30 LASIK patients over the past 18 months in my present retail location, ranging anywhere from 1mo post-ops to 15 years post.

By and large, 90% of them were happy with the procedure, their vision and the value. Most were 20/20 or better OU. A few had dryness issues, which would be expected given my patient population trends towards the 45 and over crowd. Many were using readers as appropriate, and for the most part expected this as something separate from the LASIK procedure.

The presentation above was well thought out and a nice review of the literature, but Waxler nonetheless came off with a bit of a chip on his shoulder. From what I've seen in the video, most of the sources and date were compiled before 2005 and that should be taken into consideration.

Overall my experiences with LASIK patients have been exceptionally positive. I suspect there are a few reasons for this: 1: one of the major players in our area is blade-less and that has reduced significantly the post-operative risks, DLK, etc; 2: the move in general towards pushing full-custom procedures, and 3: arguably because the markedly negative outcomes are either managed in-house by the surgery centers or going elsewhere for chronic management.

I won't refer any of my patients to some of the local surgery centers due to their business practices and methodology; however there are 2-3 excellent LASIK providers in the area that again seem to have a 90+% satisfaction rate when *I* ask the patient about their experiences.

Assuming ethical disclosure of risks with LASIK, I don't see the issue. Along with any elective surgery, we intuitively know there are risks and potential side effects. Some surgeons and centers have significantly better outcomes than others; dumping them all into the same data set can also be misleading. Technology marches forward and much like cataract extractions with IOLs, outcomes today are significantly improved when compared to X years prior - I'd expect the argument for/against LASIK to likewise be different present-day compared to the risk profile of 10 or 20 years ago; given the proliferation of fematosecond lasers, etc.

And we could have a similar argument for/against extended wear contact lenses regarding long-term risks (over wear, infections, increased need for care due to complications, outcomes present-day vs 20 years ago, etc)... IMHO.
 
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Greg Gemoules

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I still see unhappy LASIK patients in my practice and get emails from them. One of the primary reasons is that surgeons continue to believe that pupil size is of no predictive value. Most of my patients are younger and have very large pupils. Now they hate going out at night.

If nothing else, then next time you do a LASIK workup, please make an effort to get a good measurement of the dark-adapted pupil.
 

Matt Judd

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digging up an old thread, but I would agree with the above opinion: most cases of LASIK issues was in patient selection et al
 

AdminWolf

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digging up an old thread, but I would agree with the above opinion: most cases of LASIK issues was in patient selection et al

this was a fun show to do, I've resurrected the video as well, his change of heart was fascinating.
 

AdminWolf

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certainly created a lot of controversy. amazing what you learn when you click the webinars tab just for fun
Paul and I could (and should) do a better job about highlighting old content -- there's a treasure-trove of information buried on the site.

With the redesign, it should become easier for us to feature 'classic' shows!

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