Exposing the LASIK Scam

Retreatment with conventional LASIK superior? What????????

I thought wavefront was supposed to be the great savior for thousands of patients damaged by conventional LASIK. i thought this was how the greedy surgeons were going to purge their conscience of guilt, by developing an effective technology. I thought this was why Surgical Eyes didnt raise a stink, because there were effective treatment options in the works.

Now I know why the homepage of this site talks about the "hoax known as wavefront"

Back when I first had LASIK, I was told to wait for wavefront custom LASIK which would be approved in approximately 2 years and would be able to fix my problems. Interestingly the statute of limitations on medical malpractice in my state is 2 years. Coincidence?

I'm glad I quickly realized that you can't trust refractive surgeons. I later had an Artemis scan done and learned I only have 300 microns under the flap.

From the April, 2006 Journal of Refractive Surgery.
RETREATMENT OF LASIK

"It is imperative to leave a residual bed thickness of >300 um following repeat ablation".

EyeWorld
April 2006

Visual experience and patient satisfaction with wavefront-guided laser in situ keratomileusis

by Kuang-mon Ashley Tuan, OD, Ph.D.

To see if there was a link between post-op clinical measurements and patient perceptions after LASIK, investigators here launched a retrospective analysis. The study included 274 myopic astigmatic eyes of patients who had undergone wavefront-guided treatment. When investigators compared questionnaire responses to clinical measurements, they determined that patients as a rule tended to be ?more satisfied? after LASIK than before. There was as much as a 70% increase in all areas of visual satisfaction for those who were deemed ?very satisfied? with the procedure. Patients tended to be more outspoken about visual decline than they were about visual improvement. Men tended to report problems with night vision more frequently than women, although the visual changes were the same in both groups. Mesopic contrast sensitivity and mesopic contrast sensitivity under glare seemed to be linked to perceptions of change in vision. The foremost predictor for the majority of questionnaire items appeared to be residual refractive error. The conclusion reached here was that following LASIK most patients are as satisfied or more satisfied with their uncorrected acuity as they were with their best correct acuity preoperatively. Practitioners can in some cases avert potential dissatisfaction with the procedure by instilling realistic expectations and educating patients before surgery.



OMIGOSH! It says here that some patients had residual refractive error after wavefront guided LASIK. How can that be? Wavefront can't even fully correct what glasses can correct???? Could wavefront be a hoax???

J Cataract Refract Surg. 2006 Mar;32(3):475-9.


CustomVue laser in situ keratomileusis for myopia and myopic astigmatism using the Visx S4 excimer laser: Efficacy, predictability, and safety.

Partal AE, Manche EE.

Stanford University School of Medicine, Stanford, California 94305, USA.

PURPOSE: To evaluate the efficacy, predictability, and safety of custom laser in situ keratomileusis (LASIK) using the Visx wavefront platform CustomVue for the treatment of myopia and myopic astigmatism.

SETTING: Stanford University Eye Laser Center, Stanford, California, USA.

METHODS: This retrospective analysis was of the initial 140 eyes of 78 patients treated consecutively with LASIK for myopia using the Visx Star S4 excimer laser. Primary outcome variables, including uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, and complications, were evaluated at 1 week and 1 and 3 months. Vector analysis was performed on eyes that received astigmatic correction.

RESULTS: Mean preoperative spherical equivalent (SE) was reduced from -3.89 diopters +/- 1.48 (SD) to an SE of -0.21 +/- 0.36 D at 1 month and -0.28 +/- 0.36 D at 3 months (P < .001). At 1 and 3 months, UCVA was 20/20 or better in 84.3% and 87.9%, respectively. Eighty-six percent of eyes at 1 month and 81.4% of eyes at 3 months were within +/-0.5 D of emmetropia. No eyes lost more than 2 lines of BSCVA. Vector analysis yielded an index of success of 0.39, indicating a 61% success rate in achieving the astigmatic surgical correction at 3 months. The preoperative root-mean-square value of 0.28 +/- 0.08 microm increased slightly to 0.33 +/- 0.11 microm at 1 month and 0.34 +/- 0.11 microm at 3 months.

CONCLUSION: Wavefront-guided LASIK using the Visx CustomVue system was effective, predictable, and safe for correction of low to moderate myopic refractive error.


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Notice how the conclusion DOES NOT SAY CustomVue was effective at reducing the higher order RMS values???? And this only applies to patients with average to small pupil sizes because VISX's aberrometer cannot measure large pupils!!!! And 12% of patients' vision could be improved with glasses at 3 months!!!!! This hardly sounds like supervision to me!!! Could wavefront be a marketing hoax????

http://www.slackbooks.com/excerpts/66259/66259.asp

"To date, there are no reliable methods to preoperatively classify patients
according to their wound healing response. The ideal evaluation of patients
for the customized ablation may need to include not only detailed wavefront
profiles but also wound healing patterns. We need a greater understanding of
events involved in the tissue remodeling process in order to devise
objective tests to characterize and classify patients according to their
potential healing response."

All lasers, as a general rule will induce aberrations. Lasers will alter every eye, damaging most. Wavefront isnt reliable in reducing aberrations, expecially not in normal, healthy eyes. If you really want good, crisp vision, get RGP contacts. That technology will just improve and offer much better corrected vision than LASIK. I know many people dont like glasses, but its much easier to deal with glasses than your ruined, aberrated eyes after lasik.

Cataract & Refractive Surgery Today

LASIK Laser Platforms
FDA comparisons and one surgeon's experience.
By Michael Gordon, MD

http://www.crstoday.com/PDF%20Articles/ ... 06_05.html

"I was paying $100 more per eye for customized treatments, with no added advantage in the outcomes of the procedures. "

Roger Bratt has a web site about Dr. Gordon in which he wrote

"Did My Experience with "Doctor" Michael Gordon Involve a Deliberate Act of Consumer Fraud?" http://users.tns.net/~equity/LASIK_Casualties_SD/

Review of Ophthalmology

The Trouble with Wavefront

The improved outcomes seen with custom ablation may not be attributable to this technology at all.

Christopher Kent, Senior Editor

Excerpts:

"Three changes have been made to the software in wavefront-guided systems that haven't been made to standard system software, at least in the United States," he says. "As a result, wavefront-guided ablations do three things standard ablations do not: They keep the cornea prolate, produce larger astigmatic corrections, and reduce the formation of central islands. I believe these three changes account for the improvement in performance seen in comparative studies."

"In fact, Dr. Holladay says that the whole idea of correcting higher-order aberrations by ablating the cornea is fundamentally flawed. "The Food and Drug Administration won't allow manufacturers to claim that these systems correct higher-order aberrations, because manufacturer's studies for FDA approval haven't provided any scientific evidence that they do."

"Releasing the stretch on the LASIK flap induces aberration. Dr. Holladay notes that when tissue is stretched, irregularities are smoothed out. This is why a fully inflated rubber balloon is shiny, producing a clear reflection, but the surface loses its optical smoothness and doesn't produce a clear reflected image as it deflates. He notes that the same principle applies to corneal tissue. "Before a LASIK flap is cut, the corneal collagen fibers are under tension created by intraocular pressure. Once we cut the flap, the corneal fibers in the flap are no longer on stretch and optical smoothness is reduced."

Read the entire article at: http://www.revophth.com/index.asp?page=1_661.htm

Note: I found this to be very informative. I recommend you read the entire article!

Oh, this is good. Retreating wavefront-guided LASIK eyes with conventional LASIK. If wavefront is really the Cadillac of LASIK, why are they trying to "fix" them with Hyundai parts?

Ophthalmology. 2006 Jul 5; [Epub ahead of print]

Retreatment after Wavefront-Guided and Standard Myopic LASIK.Jin GJ, Merkley KH.

Eye Institute of Utah, Salt Lake City, Utah.

PURPOSE: To assess and compare the clinical outcomes of conventional LASIK retreatments after primary wavefront-guided and standard myopic LASIK.

DESIGN: Retrospective review of interventional case series.

PARTICIPANTS: One hundred fifty-four eyes of 114 consecutive patients underwent a conventional LASIK retreatment after previous wavefront-guided and standard myopic LASIK. The eyes were divided into two groups: standard conventional myopic LASIK (SM) (n = 101) and wavefront-guided myopic LASIK (WM) (n = 53).

INTERVENTION: Retreatment LASIK was performed by lifting the original flap and using an excimer laser.

MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, and complications were evaluated at a mean follow-up of 7.8+/-5.5 months after retreatment (range, 3-26).

RESULTS: At the last visit, mean spherical equivalents (SEs) were -0.17+/-0.42 diopters (D) in the SM group and -0.11+/-0.34 D in the WM group (P = 0.394). An SE of +/-0.50 D was achieved in 87% (88/101) of SM eyes and 91% (49/53) of WM eyes. Seventy-five percent of eyes in both groups had UCVA>/=20/20. All eyes in the WM group and 98% of eyes in the SM group had 20/30 or better UCVA. All eyes in both groups had a postoperative BSCVA of 20/25 or better. No eyes lost 2 lines of BSCVA in either group. No sight-threatening complications were encountered. The number of eyes with pre-retreatment optical symptoms was reduced to half after retreatment.

CONCLUSIONS: Our results suggest that retreatment with conventional LASIK is a safe, effective, predictable way of dealing with different types of residual refractive errors after both wavefront-guided and standard myopic LASIK.

Here's a wavefront success story:
http://www.lasikflap.com/forum/viewtopic.php?t=783

Broken eyes, I read this and am left scratching my head if wavefront is just a gimmick? Your post about conventional lasik enhancements over previous wavefront lasik left me wondering. If wavefront is supposed to be "better" then why are there so many lingering 'challenges', and why is conventional lasik still being performed at all? I know all forms of laser surgury induce more high order aberrations - so this would mean even "wavefront" doesnt live up to its promise?

Generally, wavefront-guided LASIK is an improvement (slight quality of vision improvement) over conventional LASIK, but it's still LASIK with all of it's nasty side effects such as severed corneal nerves that never fully regenerate (dry eyes) and a flap that never heals, and a permanently weakened cornea, and all of the other complications of LASIK. The only advantage of wavefront is a *smaller INDUCTION* of higher order aberrations. Notice I did not say, REDUCTION of higher order aberrations. Yeah, it's pretty much a marketing gimmick. I see a lot of misleading ads about wavefront -- they want patients to believe that the days of night vision disturbances is over. NOT TRUE!!! Especially for patients with large pupils.

Ophthalmology. 2004 Dec;111(12):2175-85.

Wavefront-guided LASIK with the Zyoptix 3.1 system for the correction of myopia and compound myopic astigmatism with 1-year follow-up: clinical outcome and change in higher order aberrations.

Kohnen T, Buhren J, Kuhne C, Mirshahi A.

Department of Ophthalmology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany. kohnen@em.uni-frankfurt.de

OBJECTIVE: To assess safety, efficacy, predictability, stability, and change in aberrations after wavefront-guided LASIK for myopia and myopic astigmatism.

DESIGN: Prospective, nonrandomized, self-controlled trial.

PARTICIPANTS: Wavefront-guided LASIK was performed in 97 eyes in a 1-year trial. Treated eyes had a mean subjective manifest spherical equivalent (SE) of -5.22+/-2.07 diopters (D), with a range of -0.25 to -9.00 D of myopia and 0 to -3.25 D of astigmatism.

INTERVENTION: After a microkeratome cut, a wavefront-based excimer ablation (Zyoptix 3.1) was performed. The full treatment to achieve emmetropia of an early nomogram provided by the system manufacturer was used in all procedures.

MAIN OUTCOME MEASURES: Safety, efficacy, predictability, and stability were evaluated at 1, 3, and 12 months postoperatively. Wavefront changes of higher order aberrations (HOAs) at 1 year were determined for pupil sizes of 3.5 and 6 mm. RESULTS: At 1 year postoperatively, uncorrected visual acuity (VA) was 20/20 or better in 83% of the eyes, and 20/40 or better in 98%. The mean subjective manifest SE at 1 year was -0.25+/-0.43 D; it was within 0.50 D in 77% and within 1.0 D in 95%. No eye lost > or =2 lines of best spectacle-corrected VA (BSCVA) at 1 year postoperatively; 40 eyes gained 1 line of BSCVA, and 5 eyes gained 2 lines. The total HOA root mean square (RMS) increased on average by a factor of 1.23+/-0.57 with a 3.5-mm pupil; for the 6 mm pupil, the increase factor was 1.52+/-0.36. No change or reduction in the total HOA RMS was observed in 45.5% of the eyes for a 3.5-mm pupil and in 20.6% for a 6-mm pupil. There was a significant increase of primary spherical aberration (Z 4,0) by a factor of 4.11+/-10.17 for 3.5-mm pupils and 4.31+/-6.76 for 6-mm pupils.

CONCLUSIONS: Wavefront-guided LASIK using Zyoptix 3.1 is an effective and safe procedure for the treatment of myopia and myopic astigmatism. Although in close to half of the eyes HOAs could be reduced, there was still undercorrection and induction of HOAs with the algorithm employed.



BE's comment: Notice how they reported the post-op wavefront measurements at a 3.5 mm pupil and 6.0 mm pupil. They wouldn't DARE report the wavefront measurements larger than 6.0 mm because the INCREASE in HOAs would be ALARMING!!! How do they get away with this? These numbers are meaningless to patients with pupils larger than 6.0 mm. As I've said many times before, that's like weighing a 250 lbs. woman on a scale that only goes up to 150 lbs. This is a perfect example of the way the industry covers up the continuing problem of visual impairment in dim light in patients with large pupils!

Thanks for the information! Let me comment:

"with a range of -0.25 to -9.00 D of myopia and 0 to -3.25 D of astigmatism."

Any surgeon that does lasik on -.25 myopia, unless the eye has significent astigmatism is doing malpractice. Even doing lasik on -1 sphere with little or no astigmatism borders on malpractice. -1 myopes don't have much dependancy on glasses, why would they ruin their eyes when they see fine without glasses most of the time in the first place?

"At 1 year postoperatively, uncorrected visual acuity (VA) was 20/20 or better in 83% of the eyes"


That is an exaggeration, surgeons use tricks and tactics to inflate the 20/20 results. I know someone who got lasik who guessed one of the 20/20 letters correctly and he was told he had "20/20" vision And besides, regression is common. Lasik will not stop your eyes from changing.

"for the 6 mm pupil, the increase factor was 1.52"

That is more than 50% increase in aberrations.

"CONCLUSIONS: Wavefront-guided LASIK using Zyoptix 3.1 is an effective and safe procedure for the treatment of myopia and myopic astigmatism."

Effective? Debatable, but shown to reduce dependancy on glasses. Safe? Sbsolutely not!

They cant even reliably correct you to plano like glasses can and to top it off, aberrations are induced. "Reduction" in aberrations means compared to standard lasik. Its marketing jagon to fool the unsuspecting. I used to think wavefront *reduced* aberrations compared to a virgin eye, but that is false. It "reduces" aberrations compared to standard lasik - in other words, standard lasik induces many aberrations, wavefront induces fewer aberrations, hence a "reduction" compared to standard lasik.