Exposing the LASIK Scam

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 Post subject: 35% LASIK INDUCED DRY EYE, PERSISTS PAST 6 MONTHS
PostPosted: Sat Feb 25, 2006 2:01 am 
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Am J Ophthalmol. 2006 Mar;141(3):438-45.


The incidence and risk factors for developing dry eye after myopic LASIK.

De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, Wilhelmus KR, Pflugfelder SC.

Department of Ophthalmology, Cullen Eye Institute, Baylor College of Medicine, Houston, Texas.

PURPOSE: To determine the incidence of dry eye and its risk factors after myopic laser-assisted in situ keratomileusis (LASIK).

DESIGN: Single-center, prospective randomized clinical trial of 35 adult patients, aged 24 to 54 years, with myopia undergoing LASIK.

METHODS: setting and study population: Participants were randomized to undergo LASIK with a superior or a nasal hinge flap. They were evaluated at 1 week and 1, 3, and 6 months after surgery. intervention: Bilateral LASIK with either a superior-hinge Hansatome microkeratome (n = 17) or a nasal-hinge Amadeus microkeratome (n = 18). main outcome measures: The criterion for dry eye was a total corneal fluorescein staining score >/=3. Visual acuity, ocular surface parameters, and corneal sensitivity were also analyzed. Cox proportional-hazard regression was used to assess rate ratios (RRs) with 95% confidence intervals.

RESULTS: The incidence of dry eye in the nasal- and superior-hinge group was eight (47.06%) of 17 and nine (52.94%) of 17 at 1 week, seven (38.89%) of 18 and seven (41.18%) of 17 at 1 month, four (25%) of 16 and three (17.65%) of 17 at 3 months, and two (12.50%) of 16 and six (35.29%) of 17 at 6 months, respectively. Dry eye was associated with level of preoperative myopia (RR 0.88/each diopter, P = .04), laser-calculated ablation depth (RR 1.01/mum, P = 0.01), and combined ablation depth and flap thickness (RR 1.01/mum, P = 0.01).

CONCLUSIONS: Dry eye occurs commonly after LASIK surgery in patients with no history of dry eye. The risk of developing dry eye is correlated with the degree of preoperative myopia and the depth of laser treatment.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


Last edited by Broken Eyes on Thu Mar 16, 2006 1:07 am, edited 1 time in total.

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 Post subject:
PostPosted: Sun Mar 12, 2006 3:04 am 
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From the full text:

Excerpts:


"The incidence of dry eye for the nasal-hinge group was zero (0%) of 18 at baseline, eight (47.06%) of 17 at 1 week, five (27.78%) of 18 at 1 month, four (25%) of 16 at 3 months, and five (31.25%) of 16 at 6 months. The incidence in eyes with superior hinge flap was zero (0%) of 17, nine (52.94%) of 17, four (23.53%) of 17, four (23.53%) of 17, and seven (41.18%) of 17 at baseline, 1 week, 1 month, 3 months, and 6 months, respectively."

"The incidence of dry eye gradually decreased over the observation period in both groups to a 36.36% overall incidence and a 41.18% incidence in the superior-hinge group at 6 months."

"On the basis of these findings, patients should be counseled about the risk of developing dry eye after LASIK..."

"Dry eye occurs commonly after laser-assisted in situ keratomileusis (LASIK) surgery in patients with no history of dry eye."

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sat Dec 23, 2006 6:52 pm 
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I had an MD tell me that across the street from this group, in Houston, Dr. Richard Yee has had terrific results with Autologous Serum eye drops that he makes from the patient's own serum. This has helped patients get through that first 6 months needed for nerve regeneration and restoration of tear film. The MD said that fortunately dry eye is a very uncommon clinical problem past the first six months. Based on this study and lack of long-term studies on dry eye post-LASIK, how could this MD make this statement? I'm sure the MD would say that his statement is based on his clinical experience, but I bet most post-LASIK dry eye sufferers lose faith in their LASIK MD by 6+ months and go see other MD's. I know I am an example of this. Therefore, the LASIK MD may not see that many of the post 6 month LASIK dry eye sufferers. Your thoughts?


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 Post subject: Every damaged patient needs to confront their MD
PostPosted: Sat Dec 23, 2006 11:14 pm 
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Yes, many patients who are dissatisfied with their surgeons flee the practice. This is a problem, because surgeons should have to face negative feedback from thier surgeries.

If you have had a bad outcome, make sure your surgeon knows about it.

Many LASIK industry representatives claim that complications such as dry eye are uncommon past the 6 month point. Clearly this is not true. Why would they say such a thing? Because LASIK is so profitable and they want to sell more. They want damaged patients to believe that they will be better in 3 months, 6 months, 9 months, with an enhancement... whatever it takes to shut them up so they can resume their mutilation of the next healthy corneas.


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 Post subject:
PostPosted: Sun Dec 24, 2006 2:41 am 
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Truly - I agree with you that it is not true that post-LASIK dry eye past 6 months is NOT uncommon. However, it seems like for it to be clearly untrue and defensible to MD's with their head in the sand, there needs to be documented proof. Unfortunately, most studies do not track longer term effects of LASIK patients so this allows MD's to make any statement they want. [/quote]


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 Post subject: Here is a study, poot methods, but it shows nerve loss!
PostPosted: Sun Dec 24, 2006 8:45 pm 
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The Mayo clinic followed patients over several years. Sadly, the methods they use overcount nerves in the damaged patients. Essentially each scan represented an area. If a scan area had no nerve they threw it out instead of counting it as 'zero'. This method has the effect if increasing the apparent nerve density in the refractive surgery patients as compared to normals. Still, they determined that the corneal refractive surgery patients lost nerve density and that this loss continued to the end of this study.

Imagine sampling two ponds to estimate the density of the fish population and throwing away any sample that did not contain a fish. This would make the pond with fewer fish appear to have a higher density than it actually does. Same problem with the methods in this study.

Corneal Nerve Damage Continues to Increase years 2-3 after LASIK
http://www.ncbi.nlm.nih.gov/entrez/quer ... query_hl=2

Invest Ophthalmol Vis Sci. 2004 Nov;45(11):3991-6.

Corneal reinnervation after LASIK: prospective 3-year longitudinal study.

Calvillo MP, McLaren JW, Hodge DO, Bourne WM.

Department of Ophthalmology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.

PURPOSE: To measure the return of innervation to the cornea during 3 years after LASIK.

METHODS: Seventeen corneas of 11 patients who had undergone LASIK to correct myopia from -2.0 D to -11.0 D were examined by confocal microscopy before surgery, and at 1, 3, 6, 12, 24, and 36 months after surgery. In all available scans, the number of nerve fiber bundles and their density (visible length of nerve per frame area), orientation (mean angle), and depth in the cornea were measured.

RESULTS: The number and density of subbasal nerves decreased >90% in the first month after LASIK. By 6 months these nerves began to recover, and by 2 years they reached densities not significantly different from those before LASIK. Between 2 and 3 years they decreased again, so that at 3 years the numbers remained <60% of the pre-LASIK numbers (P <0.001). In the stromal flap most nerve fiber bundles were also lost after LASIK, and these began recovering by the third month, but by the third year they did not reach their original numbers (P <0.001). In the stromal bed (posterior to the LASIK flap interface), there were no significant changes in nerve number or density. As the subbasal nerves returned, their mean orientation did not change from the predominantly vertical orientation before LASIK. Nerve orientation in the stromal flap and the stromal bed also did not change.

CONCLUSIONS: Both subbasal and stromal corneal nerves in LASIK flaps recover slowly and do not return to preoperative densities by 3 years after LASIK. The numbers of subbasal nerves appear to decrease between 2 and 3 years after LASIK. The orientation of the regenerated subbasal nerves remains predominantly vertical.


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 Post subject:
PostPosted: Thu Dec 28, 2006 12:44 am 
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Thanks Eye. I am aware of this study that looked at LASIK patients between 2-3 years. It certainly supports the fact that dry eye is likely more common post-LASIK since on average, LASIK patients remained less than 60% of pre-LASIK subbasal nerve #'s. However, it is not a clear cut study that points to dry eye as being a major problem with LASIK.

A LASIK MD might say that this is just one study and that they rarely see patients returning between years 2 and 3 with dry eye problems. Don't get me wrong ... I think this is a good study, but it is unfortunate that it appears to be the only one that points out some of the post-6 month risks of post-LASIK dry eye and it doesn't really get into real patient data of what % of LASIK patients are suffering from the effects of dry eye post-LASIK at 2 years, 3 years, 5 years, etc. It's too bad a study like this has not yet been done.


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 Post subject:
PostPosted: Fri Dec 29, 2006 12:49 pm 
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Gash wrote:
Thanks Eye. I am aware of this study that looked at LASIK patients between 2-3 years. It certainly supports the fact that dry eye is likely more common post-LASIK since on average, LASIK patients remained less than 60% of pre-LASIK subbasal nerve #'s. However, it is not a clear cut study that points to dry eye as being a major problem with LASIK.


Dry eye is most certainly a major problem with LASIK. The LASIK industry knows it. Many surgeons have stopped performing LASIK because of dry eye and ectasia-risk. The FDA website warns that dry eye after LASIK may be permanent. LASIK complications articles also state that dry eyes is the #1 complication of LASIK. Just as you say there are no studies proving that dry eyes is a "major problem", there are also no studies using objective tests that prove it's not. The studies with objective measures prove that it is a major problem. The AAO published a report that stated that dry eyes occurs frequently after LASIK. Look at some of the clinical trials published on the FDA website.

Gash, you keep looking for large scale studies of LASIK complications that don't exist. Look at the studies that *are* available and you'll see that dry eyes is a major problem with LASIK. If you find a study that proves it's not a problem, I'll bet that it didn't involve objective tests to detect dry eyes.


Gash wrote:
A LASIK MD might say that this is just one study and that they rarely see patients returning between years 2 and 3 with dry eye problems.


My own sister was placed on Restasis seven years after LASIK. She's had dry eyes since day 1 after LASIK. She never reported her dry eyes to anyone, anywhere. Does that mean she didn't have dry eyes?

Gash wrote:
Don't get me wrong ... I think this is a good study, but it is unfortunate that it appears to be the only one that points out some of the post-6 month risks of post-LASIK dry eye and it doesn't really get into real patient data of what % of LASIK patients are suffering from the effects of dry eye post-LASIK at 2 years, 3 years, 5 years, etc. It's too bad a study like this has not yet been done.


Don't hold your breath waiting for large scale studies. There is plenty of evidence that LASIK-induced dry eyes is a long-term problem.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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