Lasik - Patient Information Booklet

[Stardust3]

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Members don't see this ad.

The Patient Information Booklet provides data from FDA clinical trials including risks, contraindications, warnings and results. The FDA requires that every patient who is about to undergo LASIK surgery be given the Patient Information Booklet published by the laser manufacturer. Non-compliance with this FDA mandate is widespread. Each FDA-approved laser has an approval order with the Patient Information Do you know why eye doctors don't give this booklets to patients in the usa? How do you explain the huge 'worse symptoms' in ALL fda Patient Information Booklets?

Results from the last fda approved laser for lasik.
http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060004S001c.pdf
page 21
Change in best spectacle corrected visual acuity at 12 months:
1.1% - decrease at least 3 lines
2.3% - decrease 2 lines
17.8% - Decrease 1 line
page 28
Symptoms chart at 9 month:
Dryness - 26% -worse, 8.1% -significantly worse
Light sensitivity - 17.9% worse, 3.3% significantly worse
Halos - 14.6% worse, 3% significantly worse
Night driving vision - 14.6% worse, 4.2% significantly worse
Fluctuation of vision - 19.4% worse, 5.7% significantly worse

Compilation with symptoms tables from fda booklets.
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing

Kind Regards,
ST3

Morris Waxler, PhD. From 1996 to 2000 was the FDA's chief scientist in charge of the clinical trials research for laser eye surgery. Now he says:
http://www.lasikcomplications.com/Waxler_petition_FDA_stop_LASIK(6Jan11).pdf
"FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events, e.g. page 16 of the Patient Information Brochure for P970053c says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…” LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than one percent."
"LASIK manufacturers and their collaborators emphasized “patient satisfaction” to divert FDA attention from continuing LASIK-patient complaints about glare, halos, dry eye and night driving problems."
"To this moment they and their collaborators have been successfully engaged in a pattern of falsifying, misrepresenting, manipulating, and withholding safety and effectiveness data from FDA to make their LASIK devices appear safer than they are."

 

[MstaKing10]

Few key points:

- The study was performed on hyperopes and astigmatic hyperopes. This is not the usual patient population of moderate to high myopes. Perhaps someone can clarify why they did it this way but laser ablation for hyperopes (and especially high hyperopes which this study inluded, some >+5D) is much more difficult and unpredictable.
- Despite that fact, page 25 is key: in terms of uncorrected vision, 59% had 20/20 and 96% had 20/40. That's excellent results for uncorrected vision in hyperopes. Would need to do a detailed evaluation of those that did not achieve better vision but perhaps these were the higher hyperopes.
- Page 27: Self evaluation. 97.9% of patients noted an improvement in vision, 88.4% would have surgery again, 96.8% were satisfied

Not sure what your issues are regarding lasik, I'm assuming you are trying to stimulate a conversation about "shady" lasik surgeons and their practices. Good luck.

 

[ophthope]

"Pre-Optometry" poster that appears to be a non-native English speaker with an atrociously formatted and confusing post about Lasik complications? I don't think he's trying to start a real conversation. From what I can read through the copypasta his tone is accusatory.

Plenty of us Ophthalmologists have had Lasik. We aren't trying to destroy eyes for money.

Here's the website of "Waxler Regulatory Consultancy, LLC" which is where this pdf came from.

And here's a Cataract and Refractive Surgery journal article with a couple of comments in response including the following, which I very much like:

I believe that Dr. Waxler’s arguments are inappropriate and create a dangerous environment for impeding medical progress. As an analogy, we allow 16-year-olds to get a driver’s license in the state of California. Statistics suggest that a significant number of automobile-related fatalities are caused by drivers under the age of 25. Should we ban automobile manufacturers from making cars to prevent automobile accidents? Should we ban all drivers under the age of 25 from getting behind the wheel? LASIK performed by a competent surgeon on appropriate patients is a safe procedure. In my experience as a surgeon and expert witness, many bad outcomes could have been avoided with the proper selection of patients for the procedure. The practice of bad medicine is not a manufacturing issue but rather one of poor clinical decision making. Furthermore, should Dr. Waxler’s petition be granted, I can only imagine the impact of such regulations on multifocal IOL technologies.

Considering the tort industry’s success in pushing the agenda that all human activities need to be 100% safe and without side effects, it should be no surprise that a career federal bureaucrat would make such a patently absurd claim.

When I was a resident at Johns Hopkins years ago, A. Edward Maumenee, MD, counseled me with tongue in cheek that his one surefire method to guarantee no complications or dissatisfied patients was never to operate. Dr. Waxler, it seems, would like to actually implement this plan and impose a moratorium on the most frequently performed elective procedure associated with the highest level of patients’ satisfaction.

Basically this is a regulator who appears to love to regulate even when it's inappropriate to do so accusing surgeons of loving to operate even when it's inappropriate to do so. Except one of us is right and it happens to be the ones with actual experience doing surgery and unbiased data to back up safety.

 

[Stardust3]

Im non-native english speaker but i think that's not important.

Lasik results show 'good' visual acuity but that's only part of vision quality. What fda booklets show is that an huge number of patients complaint of worse night vision, worse dry eyes, worse light sensitivity, worse glare,.... This are considered mere 'symptoms' by lasik industry. It's not a complication for lasik industry, and it was the only way possible to fda approve lasers as Morris Waxler said in his petition.

It's not only one or two laser's that show huge numbers for 'worse symptom', ALL show huge numbers for worse symptoms. This charts are in fda Patient Information Booklets that 99,99% of patients don't see before lasik. Why lasik doctor's don't give this booklets to patients? It's because it show the symptoms charts? And nobody will do lasik seeing that?

Document with symptoms chart compilation from fda patient information booklets..
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing

Here is a link to the fda webpage with the list and booklets for fda approved lasers. You can read it with your own eyes. This prove lasik industry is lying to population? Someday this information will air worlwide and a big scandal will begin.
http://www.fda.gov/MedicalDevices/P...res/SurgeryandLifeSupport/LASIK/ucm192109.htm

All lasik doctors receive this documents from laser manufacturers, so they have the information but keep it top secret!

You all know and i also know that eye doctors who have done lasik themselves are a very small minority. Even with big financial interests most eye doctors still haven't done lasik. You also know that many eye doctor's don't recommend lasik to their patients and lost millions of dollars because they didn't want to be part of lasik world.

 

[ophthope]

Im non-native english speaker but i think that's not important.

Lasik results show 'good' visual acuity but that's only part of vision quality. What fda booklets show is that an huge number of patients complaint of worse night vision, worse dry eyes, worse light sensitivity, worse glare,.... This are considered mere 'symptoms' by lasik industry. It's not a complication for lasik industry, and it was the only way possible to fda approve lasers as Morris Waxler said in his petition.

It's not only one or two laser's that show huge numbers for 'worse symptom', ALL show huge numbers for worse symptoms. This charts are in fda Patient Information Booklets that 99,99% of patients don't see before lasik. Why lasik doctor's don't give this booklets to patients? It's because it show the symptoms charts? And nobody will do lasik seeing that?

Document with symptoms chart compilation from fda patient information booklets..
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing

Here is a link to the fda webpage with the list and booklets for fda approved lasers. You can read it with your own eyes. This prove lasik industry is lying to population? Someday this information will air worlwide and a big scandal will begin.
http://www.fda.gov/MedicalDevices/P...res/SurgeryandLifeSupport/LASIK/ucm192109.htm

All lasik doctors receive this documents from laser manufacturers, so they have the information but keep it top secret!

There is no problem with being a non-native English speaker, it's just that you don't communicate in English very fluently. The issue is that it is difficult to understand what you're getting at since you phrase things awkwardly. You keep saying "worse symptom" but I don't know what you mean. I understand in broad terms what you're saying, but an involved discussion about anything will necessarily involve specifics that two people speaking different languages will have difficulty communicating to each other.

The reason dry eyes and night glare aren't 'complications' is because that's not what 'complications' means. These are well known side effects, although the data you keep quoting blows the proportion way out of the water and doesn't consider that for most patients these issues resolve over time.

And good gosh the booklets. What do you think is in those booklets? Here's a paragraph from the Alegretto Wave Patient Information Booklet:

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect, 0.1% (11844) had any epitheliuim in the interface, 0.1 % (1/844) had foreign body sensation, 0.2% (2/844) had pain, and 0.7% (6/844) had ghosting or double images in the operative eye.

First off, with jargon like "corneal epithelial defect", how many patients do you think truly understanding everything in these booklets?

And lets compare this to other elective surgeries shall we? Do you know how many bariatric surgeons or plastic surgeons would kill for complication rates that low? With bariatric surgery we have discussions about the very possible risk of death before a patient goes to the OR, but you don't see people crying foul that the bariatric surgeons are just putzing around in people's guts for no reason at all just throwing in anastamoses willy-nilly!

And we don't show them the 'booklets' because they wouldn't have LASIK if they saw the 'symptom charts?' Really, have you ever even been involved in a refractive surgery evaluation? I've never seen a patient who wasn't informed about the risks of things like dry eyes and glare and even decreased visual acuity. Those risks are very small but they do exist.

You all know and i also know that eye doctors who have done lasik themselves are a very small minority. Even with big financial interests most eye doctors still haven't done lasik.

False. Many many Ophthalmologists and Optometrists have had LASIK, LASEK, or PRK themselves. I'm not sure why you think otherwise.

Something like over a quarter-million active duty US military had had refractive surgery. In fact the air force offers refractive surgery to it's pilots. If visual outcomes were so poor do you really think we'd be letting the people flying out into battle for us have this done? Here's a page from the Air Force Times about just how many refractive surgery cases Air Force Ophthalmologists have done on active duty military personnel. NASA allows astronauts to have LASIK.

I'd love to see a reason why the military trusts this technology if outcomes are so bad.

 

[Stardust3]

You post the link to the patient information booklet from Alegretto Wave. This booklet don't show the chart with symptoms rates. This is imporant to know how many say have worse dry eyes, much worse dry eyes, worse night vision, much worse night vision,..... This document only show the 'good things', that's one of the reason why many persons accuse lasik industry and fda of falsifying, misrepresenting and manipulating lasik data. The fda doctor booklet for this laser also don't show this important data.

The Alegretto Wave you post is a laser from 2003 approved to do lasik up to -12 myopia. I will post the fda booklet results from a similar laser that show the table wih worse symptoms, the TECHNOLAS® 217A Excimer Laser System, approved in 2002 to myopia up to -12.
http://www.accessdata.fda.gov/cdrh_docs/pdf/P990027S002c.pdf
page 9
Worse symptoms at 6 months.
Halos - Worse 42,9%
Blurred Vision - Worse 37,9%
Dryness, 21,4%
Night Driving Vision - 36,6%
Fluctuation of Vision - 36,6%
Glare - 29,9%
light sensitivity - 10,7%
.........................

One of the reasons why lasik will be an huge scandal is because usa navy have done thousands of lasiks. Many navy eye doctors have done millions of dollares with lasik. As you know the majority of eye doctors wear glasses and contacts because it give perfect vision without surgery. If lasik was good most eye doctors would have done lasik themselves and this didn't happen still in 2014!

Lasik doctor's don't give patient information booklets to patients because patients wil not want to do lasik. Lasik is elective surgery, and to sell it you can't talk about the 'bad things'.

Other thing, millions of google glasses will be sold this year with a lasik warning.
https://support.google.com/glass/answer/3064131?hl=en
"If you’ve had Lasik surgery, ask your doctor about risks of eye impact damage before using Glass."
http://androidheadlines.com/2013/05...r-glass-says-it-may-be-bad-for-your-eyes.html
"The company goes on to advise people who have had Lasik eye surgery to avoid wearing the device. If you’re really eager to try, then Google recommends that you go to your doctor for final approval"

Compilation with symptoms charts from fda approved lasers. To prove lasik is big fraud you only have to see this. It's the most official information about lasik, lasik doctors know this data but don't inform patients. There is nothing like this in the lasik centers webpages. Patients will not be naive forever.
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing

Remember that if patient can't drive at nigh after lasik is not a complication, if patient need eye drops for dry eyes every single day for the rest of their life is not a complication for lasik industry. It's ONLY a symptom!

 

[peter2013]

Startdust3, a little piece of advice. People are more likely to buy your argument if:
-They can understand your English
-You don't make unsupported claims
-You don't cherry pick data

I think your argument is interesting and should be addressed, but at this point it needs a whole lot of polishing to be taken seriously.

And just out of curiosity, what does a foreigner stand to gain by outlawing LASIK in the United States?

 

[Stardust3]

Im sorry for my bad english, but im from Europe. The data im posting here is from the fda, so you can't say it's unsupported claims.

Some more important data, from ASCRS.

http://www.lasiknewswire.com/2009/12/the-truth-behind-lasik-satisfaction.html

"The FDA called a public meeting in April 2008 to discuss issues concerning patients' experiences with LASIK. Several weeks prior to meeting, the American Society of Cataract and Refractive Surgery (ASCRS) -- a professional group of LASIK and cataract surgeons -- issued a press release announcing findings of a literature review led by Kerry Solomon, M.D. alleging a "95.4% global LASIK satisfaction rate". The full text of the article was not published until April 2009. Nineteen articles representing only 2,199 patients were retained by the authors in this "LASIK world literature review"3.

An inspection of articles cited in the 'global LASIK literature review' reveals alarmingly high LASIK complication rates:

"24% of patients reported glare and night vision problems postoperatively." O'Doherty M, O'Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.

"Overall, 30.0% of the subjects reported experiencing halos, 27.2% reported glare, and 24.5% reported starbursts." Bailey MD, Mitchell GL, Dhaliwal DK, et al. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Ophthalmology 2003;110:1371- 8.

"Commonly reported symptoms included eye soreness in 43 patients (44.3%), tearing in 20 (20.8%), itching in 38 (39.6%), and moderate dryness or worse in 28 (20.8%)." Schmidt GW, Yoon M, McGwin G, et al. Evaluation of the relationship between ablation diameter, pupil size, and visual function with vision-specific quality-of-life measures after laser in situ keratomileusis. Arch Ophthalmol 2007;125:1037-42.

"Night vision was considered worse or much worse than before surgery by 33.8% of patients....After surgery, 40.9% of patients reported experiencing more difficulty with night driving than before surgery."Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. J Cataract Refract Surg. 2005 Oct;31(10):1943-51.

"29% reported reduced night vision clarity following LASIK and 27% noted more eye dryness following LASIK." CLAO J. 2001 Apr;27(2):84-8. Patient satisfaction after LASIK for myopia. Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH.

Likely, surgeons are focusing on patient satisfaction to divert attention away from high complication rates inherent in the LASIK procedure.

Physicians have an obligation to place patient welfare over any personal profit motives. However, highly lucrative outpatient surgical procedures such as LASIK eye surgery have created a new breed of physician/entrepreneurs who are willing to simply sell what is profitable to a trusting and unsuspecting public. These 'salesmen' are masquerading as healers."

References

3. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701

Lasik World Literature Review led by Kerry Solomon, M.

 

[ophthope]

One of the reasons why lasik will be an huge scandal is because usa navy have done thousands of lasiks. Many navy eye doctors have done millions of dollares with lasik. As you know the majority of eye doctors wear glasses and contacts because it give perfect vision without surgery. If lasik was good most eye doctors would have done lasik themselves and this didn't happen still in 2014!

I don't think you understood that example I gave at all. Military Ophthalmologists do not make more money by doing Lasik. They are paid a salary, they don't get paid more for each Lasik case. The military personnel don't pay for the surgery. The government provides the refractive surgery to them for free.

They do so because it works, and it is safe.

And once again, Lasik is an elective surgery. Just because every single eye doctor hasn't had it done doesn't mean that it's a big conspiracy. Do you think most Facial Plastics doctors have had nosejobs? Do you think most Breast Surgeons have had augmentations? Do you think most Maxillofacial surgeons have dental implants? Do you think most Orthodontists have veneers?

Yes, contacts and glasses can provide vision correction without surgery. That is why we call refractive surgery "elective." Just like cosmetic surgery. There are risks with any surgery. There are risks associated with anything: you take a calculated risk if you ride a rollercoaster, drive your car to work, go skydiving, or any other activity.

Your lifetime risk of drowning is about 1 in 1,134. If you want to make a difference go try to convince people to never go swimming. That would of course be equally as absurd as what you are doing here.


And you keep cherry picking these quotes out of small studies like this one which was based on what appears to be a subjective survey of 142 patients in the Netherlands:

"Night vision was considered worse or much worse than before surgery by 33.8% of patients....After surgery, 40.9% of patients reported experiencing more difficulty with night driving than before surgery."Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. J Cataract Refract Surg. 2005 Oct;31(10):1943-51.

Well here's another quote from that exact same article:

A total of 92.2% of patients were satisfied or very satisfied with their surgery, 93.6% considered their main goal of surgery achieved, and 92.3% would choose to have LASIK surgery again.

If these patients considered their symptoms to be so minimal that they'd still have the surgery done again - Who are you to insist that their symptoms were more significant than they themselves deemed them to be?

All of this is likely lost on you however, because I'm still not convinced that you are fluent enough in English to understand what I am saying and your replies to my points such as the one involving military surgeons indicate to me that you have completely misunderstood some fairly large and obvious things.

 

[MstaKing10]

I'm not sure his/her English is a barrier at all. Their message is coming through crystal clear. On the other hand, I don't think Stardust has any interest in hearing the alternative views we have provided. We are spinning our wheels here and will get nowhere.

Saying Lasik is fraud is absolutely absurd and totally disqualifies Stardust as a reasonable and logical individual. Good luck to the rest of you trying to place some sense into him/her.

 

[Stardust3]

The data i posted here is from the fda (patient information booklets) and the ASCRS (lasik world literature review). This is not 'small' studys, in fact it's the biggest lasik study's from the fda and the ascrs.

There are many problems with lasik, for example the flap never heals. ZERO lasik doctors inform patients about this. Is this a fraud? Because patients aren't giving a true informed consent.

https://support.google.com/glass/answer/3064131?hl=en
"If you’ve had Lasik surgery, ask your doctor about risks of eye impact damage before using Glass."
http://androidheadlines.com/2013/05...r-glass-says-it-may-be-bad-for-your-eyes.html
"The company goes on to advise people who have had Lasik eye surgery to avoid wearing the device. If you’re really eager to try, then Google recommends that you go to your doctor for final approval"

Dr. OZ warning about lasik flap never heals.

 

[long]

You guys. He cited a Dr. Oz video. I think you're going to have to give him the win

 

[Stardust3]

Here you have some more studys.

Dr. John Kanellopoulos: “There was evidence presented by Emory University’s Henry Edelhauser at this year’s Refractive Surgery Subspecialty Day at the Academy of Ophthalmology meeting that the LASIK flap never actually heals onto the underlying stroma, especially centrally... This was a real eye-opener for me..." (Review of Ophthalmology 2/1/2009)

"To put it more simply, the corneal flap after LASIK provides no more corneal strength than the wearing of a contact lens." William Jory, MD. J Refract Surg. 2004 May-Jun;20(3):286.

"Laser in situ keratomileusis is another surgery in which the flap is prone to traumatic dislocation because the interface does not seem to heal except at the edges." Source: Protective effect of LASIK flap in penetrating keratoplasty following blunt trauma. Canto AP, Vaddavalli PK, Yoo SH, Culbertson WW, Belmont SC. J Cataract Refract Surg. 2011 Dec;37(12):2211-3.

"Although LASIK remains the most popular refractive surgical procedure, it is becoming apparent that corneal surfaces, cut to create the midstromal flap during surgery, fail to fully reunite postoperatively; surgeons can simply peel back an anterior corneal flap several years later. Such patients... are at risk for progressive visual disability due to general corneal weakness that may progress to ectasia or even traumatic displacement of the insecure flap." Source: Mi S, Dooley EP, Albon J, Boulton ME, Meek KM, Kamma-Lorger CS. Adhesion of laser in situ keratomileusis-like flaps in the cornea: Effects of crosslinking, stromal fibroblasts, and cytokine treatment. J Cataract Refract Surg. 2011 Jan;37(1):166-72.

"Delayed trauma has been shown to cause flap defects,demonstrating that LASIK flaps remain vulnerable to traumatic dehiscence and dislocation even 6 or 7 years after surgery." Source: Roxana Ursea, MD and Matthew T. Feng, MD. Traumatic Flap Striae 6 Years After LASIK: Case Report and Literature Review. J Refract Surg. Vol. 26 No. 11 November 2010

Dr. George O. Waring III: "This means you can lift the LASIK flap indefinitely after LASIK. My longest personal LASIK flap lift is 12 years, and it was done very easily. We have performed biomechanical studies now at Emory up to eight years post-operatively and find that the strength of the lamellar wound is about 2 percent of the normal cornea."
Source: Am J Ophthalmol. 2006 May;141(5):799-809. Peer Discussion: Corneal keratocyte deficits after photorefractive keratectomy and laser in situ keratomileusis.

"The LASIK flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed..." (O'Brart et al, 2007)

""I was in the middle of trephining a donor cornea, when it fell apart," he said. "Fortunately, we were able to send a new cornea right away, and the surgeon finished the operation," said Ronald E. Smith, MD, medical director of the Doheny Eye Bank in Los Angeles. Later, back at the eye bank, researchers examined the ruined cornea and determined that it had had LASIK." Source: Laura J. Ronge. LASIK Shatters Assumptions. EyeNet, August 2001. Read article

"Another aspect of LASIK surgery is that during this procedure, a corneal flap is made, which will create lifelong lamellar corneal potential space." J Refract Surg. 2006 May;22(5):441-7. Galal et al.

"However, this case illustrates that even 4 years following the procedure, the lamellar flap remains an inherently weakened area of the eye, susceptible to traumatic disruption." Source: Nilforoushan MR, Speaker MG, Latkany R. Traumatic flap dislocation 4 years after laser in situ keratomileusis. J Cataract Refract Surg. 2005 Aug;31(8):1664-5.

"Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force." Source (pg 4)

Dr. Gary Conrad, Kansas State University Biology Professor: "It was once believed that the flap would re-adhere permanently. However, the unique connective tissue of the cornea and a lack of blood vessels limit its ability to fully heal even years after the procedure." Source

"The corneal flap of approximately 160 μm, of one third thickness of the average cornea, has been shown to never heal fully by Seiler and Marshall (personal communication, June 26, 2000). Approximately 22 million corneal fibers are intersected, their severed ends never rejoining, meaning that the flap is held in place only by glycosaminoglycans and peripheral scar tissue. To put it more simply, the corneal flap after LASIK provides no more corneal strength than the wearing of a contact lens." Jory W. Corneal ectasia after LASIK. J Refract Surg. 2004 May-Jun;20(3):286.

"Furthermore, if [LASIK] interface transparency is indicative of absent wound healing, one might expect that the interface remains a potential space and flap adhesion is impaired for the lifetime of the flap." (Ursea and Feng, 2009)

 

[ophthope]

There are many problems with lasik, for example the flap never heals. ZERO lasik doctors inform patients about this. Is this a fraud? Because patients aren't giving a true informed consent.

You're either:
1. Completely full of crap OR
2. Completely misinformed OR
3. Both

I've never seen a discussion about Lasik where flap complications weren't mentioned. In fact, a ton of patients ask questions about flap healing because they're worried about it. And if the patient wants PRK or epi-LASEK instead (where there is NO CORNEAL FLAP AT ALL) then they have that option.

I don't even think you understand what types of refractive surgery exist. Are you telling us that you have no problem with PRK or epi-LASEK, only with LASIK?

And you can't keep coming here and telling us what Ophthalmologists do and do not inform patients about. You have zero experience in this matter and we are the Ophthalmologists you're talking about. So when you say that "lasik doctors" don't inform patients about this, I can tell you that you're flat-out wrong because I have been a part of pre-operative Lasik evaluations and discussions where flap complications were discussed.

 

[member298122]

Here you have some more studys.

Dr. John Kanellopoulos: “There was evidence presented by Emory University’s Henry Edelhauser at this year’s Refractive Surgery Subspecialty Day at the Academy of Ophthalmology meeting that the LASIK flap never actually heals onto the underlying stroma, especially centrally... This was a real eye-opener for me..." (Review of Ophthalmology 2/1/2009)

"To put it more simply, the corneal flap after LASIK provides no more corneal strength than the wearing of a contact lens." William Jory, MD. J Refract Surg. 2004 May-Jun;20(3):286.

"Laser in situ keratomileusis is another surgery in which the flap is prone to traumatic dislocation because the interface does not seem to heal except at the edges." Source: Protective effect of LASIK flap in penetrating keratoplasty following blunt trauma. Canto AP, Vaddavalli PK, Yoo SH, Culbertson WW, Belmont SC. J Cataract Refract Surg. 2011 Dec;37(12):2211-3.

"Although LASIK remains the most popular refractive surgical procedure, it is becoming apparent that corneal surfaces, cut to create the midstromal flap during surgery, fail to fully reunite postoperatively; surgeons can simply peel back an anterior corneal flap several years later. Such patients... are at risk for progressive visual disability due to general corneal weakness that may progress to ectasia or even traumatic displacement of the insecure flap." Source: Mi S, Dooley EP, Albon J, Boulton ME, Meek KM, Kamma-Lorger CS. Adhesion of laser in situ keratomileusis-like flaps in the cornea: Effects of crosslinking, stromal fibroblasts, and cytokine treatment. J Cataract Refract Surg. 2011 Jan;37(1):166-72.

"Delayed trauma has been shown to cause flap defects,demonstrating that LASIK flaps remain vulnerable to traumatic dehiscence and dislocation even 6 or 7 years after surgery." Source: Roxana Ursea, MD and Matthew T. Feng, MD. Traumatic Flap Striae 6 Years After LASIK: Case Report and Literature Review. J Refract Surg. Vol. 26 No. 11 November 2010

Dr. George O. Waring III: "This means you can lift the LASIK flap indefinitely after LASIK. My longest personal LASIK flap lift is 12 years, and it was done very easily. We have performed biomechanical studies now at Emory up to eight years post-operatively and find that the strength of the lamellar wound is about 2 percent of the normal cornea."
Source: Am J Ophthalmol. 2006 May;141(5):799-809. Peer Discussion: Corneal keratocyte deficits after photorefractive keratectomy and laser in situ keratomileusis.

"The LASIK flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed..." (O'Brart et al, 2007)

""I was in the middle of trephining a donor cornea, when it fell apart," he said. "Fortunately, we were able to send a new cornea right away, and the surgeon finished the operation," said Ronald E. Smith, MD, medical director of the Doheny Eye Bank in Los Angeles. Later, back at the eye bank, researchers examined the ruined cornea and determined that it had had LASIK." Source: Laura J. Ronge. LASIK Shatters Assumptions. EyeNet, August 2001. Read article

"Another aspect of LASIK surgery is that during this procedure, a corneal flap is made, which will create lifelong lamellar corneal potential space." J Refract Surg. 2006 May;22(5):441-7. Galal et al.

"However, this case illustrates that even 4 years following the procedure, the lamellar flap remains an inherently weakened area of the eye, susceptible to traumatic disruption." Source: Nilforoushan MR, Speaker MG, Latkany R. Traumatic flap dislocation 4 years after laser in situ keratomileusis. J Cataract Refract Surg. 2005 Aug;31(8):1664-5.

"Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force." Source (pg 4)

Dr. Gary Conrad, Kansas State University Biology Professor: "It was once believed that the flap would re-adhere permanently. However, the unique connective tissue of the cornea and a lack of blood vessels limit its ability to fully heal even years after the procedure." Source

"The corneal flap of approximately 160 μm, of one third thickness of the average cornea, has been shown to never heal fully by Seiler and Marshall (personal communication, June 26, 2000). Approximately 22 million corneal fibers are intersected, their severed ends never rejoining, meaning that the flap is held in place only by glycosaminoglycans and peripheral scar tissue. To put it more simply, the corneal flap after LASIK provides no more corneal strength than the wearing of a contact lens." Jory W. Corneal ectasia after LASIK. J Refract Surg. 2004 May-Jun;20(3):286.

"Furthermore, if [LASIK] interface transparency is indicative of absent wound healing, one might expect that the interface remains a potential space and flap adhesion is impaired for the lifetime of the flap." (Ursea and Feng, 2009)

Ridiculous threat by an obviously oblivious person. Lasik informed consents are likely the most thorough in all of medicine given the highly litigious nature of elective eye surgery. A lot of refractive guys make patients watch 30-45 minute informative videos which outline every possible complication as part of this consent process to protect themselves. The thought of hiding potential complications from lasik patients is beyond preposterous, the lawsuit would've already happened and made the front page of cnn...
I am not a refractive guy, but was impressed at the detail these guys go through during the informed consent process when I rotated with them in residency.

 

[Stardust3]

ophthope, I don't know one lasik patient that was informed by lasik doctor that flap never heals. Also tell me ONE lasik center website that says the flap never heals! Lasik centers websites only have bs to sell more lasik and we all know that!

Do you know Bowman's Membrane is removed forever and never grow back after surface ablation (prk, lasek,..)?

Lasik will be an huge scandal! This year millions of google glass devices will bring a lasik warning. Lasik doctors will not be able to continue lying forever! Someday Patient Information Booklets will air on tv, and population will be very mad with lasik doctors and eye doctors!

Remember for example if patient can't drive at night he only have 'worse night vision'. If patient have to put drops for dry eyes every single day he only have 'worse dry eyes'. Near ZERO lasik doctors give pib to patients, and it's very easy to know why! Patients aren't giving a true informed consent. The % for 'worse symptoms' are HUGE!
Patient Information Booklet compilation with symptoms tables.
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing

To make money from lasik, eye doctors have to lie. You also know that many eye doctors are against lasik.
http://forums.studentdoctor.net/threads/lasik-compensation.923495/
"My uncle lives in a 9000 Square Foot home in Short Hills NJ and he has 4 cars that are over 200,000. He is a LASIK Eye Surgeon, how much do they earn?"

 

[Stardust3]

Lasik Doctors are.....