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Message from discussion THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
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trulytell...@yahoo.com  
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 More options Aug 25 2006, 5:48 pm
Newsgroups: alt.lasik-eyes
From: Trulytell...@yahoo.com
Date: 25 Aug 2006 14:48:59 -0700
Local: Fri, Aug 25 2006 5:48 pm
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006

Ace wrote:
> Cataract Surgery after LASIK
> Like the general population, LASIK patients will develop cataracts
> later in life. The altered corneal surface following LASIK prevents
> accurate measurement of intraocular lens power for cataract surgery.
> This may result in a "refractive surprise" for LASIK patients
> following cataract surgery and exposes them to increased risk of repeat
> surgeries.

> LASIK Results in Loss of Near Vision
> Patients are routinely misinformed that they will require reading
> glasses after the age of 40 whether they have LASIK or not. Nearsighted
> patients who do not have refractive surgery actually retain the ability
> to see up close naturally after the age of 40 simply by removing their
> glasses. LASIK increases the need for reading glasses by changing the
> eye's focus from near to distance. The loss of near vision after
> myopic-LASIK affects many daily activities, not just reading. LASIK
> patients over the age of 40 may discover they have simply traded one
> pair of glasses for another.

> VII. PATIENT SATISFACTION

> LASIK success is measured by the LASIK industry as uncorrected visual
> acuity under bright illumination. Patients seeking vision correction
> are most concerned with elimination of glasses or contact lenses, and
> are unaware what it means to lose visual quality. Patient surveys
> typically show a high level of satisfaction with LASIK. However, an
> alarming number of 'satisfied' patients also report symptoms such
> as visual disturbances in dim light and dry eye.

> In May, 2001, results from a questionnaire completed by PRK and LASIK
> patients revealed that 19.5% reported a worsening in functioning, 27.1%
> a worsening in symptoms, 34.9% a worsening in optical problems, 33.7% a
> worsening in glare, and 41.5% a worsening in driving.27

> In one report, researchers suggest that factors such as the Hawthorne
> effect and cognitive dissonance may play a role in patient satisfaction
> following LASIK.28 The Hawthorne effect favorably influences
> patients' survey responses merely because patients are aware that
> they are enrolled in a study. Cognitive dissonance is a change in
> one's attitude or beliefs to eliminate internal conflict with
> negative consequences of an irreversible action.

> VIII. NEWER TECHNOLOGIES

> Wavefront-guided and wavefront-optimized LASIK
> Newer laser technologies were designed to reduce induction of new
> aberrations and prevent night vision disturbances. As complications
> from current technologies generate bad publicity, pressure to develop
> and market alternative technologies emerge. "Real" complication
> rates are openly discussed, not when a procedure is popular, but rather
> when providers push newer, "improved" technology. The LASIK
> industry and LASIK surgeons aggressively promote new technologies as
> "safer and more effective", blaming older technologies for past
> complications. Although the introduction of wavefront-LASIK was
> surrounded by hype, studies have shown that wavefront-guided and
> wavefront-optimized LASIK actually increase, not decrease, higher order
> aberrations, reducing visual quality in previously untreated eyes.29,30
> A recently published review of literature on wavefront-guided LASIK
> concludes that evidence does not support claims that wavefront
> outperforms conventional LASIK.31 Wavefront, like previous forms of
> refractive surgery, fails to deliver on its promises.

> Femtosecond laser flap creation (Intralase-LASIK)
> Mechanical blade microkeratomes have been linked to flap complications
> and damage to the epithelium. The femtosecond laser keratome is
> currently promoted as a safer alternative. Studies have shown that the
> femtosecond laser produces flaps with smaller deviations from planned
> thickness than mechanical microkeratomes. However, it does not reduce
> most complications associated with the LASIK procedure and has been
> linked to extreme light sensitivity,32 a new complication of this
> technology. Femtosecond laser flaps are more difficult to lift than
> flaps created with a blade, which may result in a higher incidence of
> torn flaps.

> The femtosecond laser keratome currently requires longer suction on the
> eye than blade microkeratomes to create the LASIK flap. The incidence
> of posterior vitreous detachment with blade microkeratomes is high, at
> 13% overall and 24% for patients with high myopia.33 Increased suction
> ring exposure associated with use of femtosecond lasers likely induces
> posterior vitreous detachment at even higher rates as well as other
> serious complications such as retinal detachment, macular hemorrhage,
> retinal vein occlusion, and optic nerve damage following LASIK.

> A search of peer-reviewed literature reveals problems associated with
> the femtosecond laser such as slipped flaps, interface inflammation,
> flap folds, infectious keratitis, corneal stromal inflammation, delayed
> wound healing, macular hemorrhage, and gas bubbles in the anterior
> chamber after surgery.34-40 The FDA medical device adverse events
> database (http://www.fda.gov/cdrh/maude.html) contains numerous reports
> involving femtosecond laser keratomes.

> IX. CONCLUSION

> Patients are denied the whole truth about the negative effects of
> LASIK; therefore they are unable to give informed consent. The LASIK
> industry has been unresponsive to results of medical research, which
> should have resulted in a higher standard of care. Instead, LASIK
> surgeons have resisted raising the standard of care in order to
> maintain the potential pool of candidates and to protect themselves
> from liability.

> The American Medical Association endorses certain principles of medical
> ethics. One principle states that: "A physician shall uphold the
> standards of professionalism, be honest in all professional
> interactions, and strive to report physicians deficient in character or
> competence, or engaging in fraud or deception, to appropriate
> entities." (http://www.ama-assn.org/ama/pub/category/2512.html). The
> white wall of silence called for by Dr. McDonald in 1999 violates this
> principle.

> There has been and continues to be a pattern within the refractive
> surgery industry placing patients' interests secondary to financial
> interests. Medical doctors are ethically bound to put the best
> interests of patients first. LASIK is an unnecessary surgical procedure
> that permanently damages the eyes of every patient; therefore it is a
> violation of a primary principle of medicine, "First, Do No Harm". As
> such, the practice of LASIK should be discontinued.

> References

> 1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ,
> de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and
> astigmatism: Safety and efficacy. A report by the American Academy of
> Ophthlamology. Ophthalmology. 2002 Jan;109(1):175-87.

> 2. Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and
> recurrent erosion syndrome after refractive surgery. J Cataract Refract
> Surg. 2001 Apr;27(4):577-84.

> 3. Calvillo MP, McLaren JW, Hodge DO, Bourne WM. Corneal reinnervation
> after LASIK: prospective 3-year longitudinal study. Invest Ophthalmol
> Vis Sci. 2004 Nov;45(11):3991-6.

> 4. De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS,
> Wilhelmus KR, Pflugfelder SC. The incidence and risk factors for
> developing dry eye after myopic LASIK. Am J Ophthalmol. 2006 Mar;
> 141(3):438-45.

> 5. Schwiegerling J, Snyder RW. Corneal ablation patterns to correct for
> spherical aberration in photorefractive keratectomy. J Cataract Refract
> Surg. 2000 Feb;26(2):214-21.

> 6. Hersh PS, Fry K, Blaker JW. Spherical aberration after laser in situ
> keratomileusis and photorefractive keratectomy. Clinical results and
> theoretical models of etiology. J Cataract Refract Surg. 2003
> Nov;29(11):2096-104.

> 7. Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront optimized
> ablation profiles. Theoretical background. J Cataract Refract Surg.
> 2004 Apr;30(4):775-85.

> 8. Netto MV, Ambrosio R Jr, Wilson SE. Pupil size in refractive surgery
> candidates. J of Refract Surg. 2004 Jul-Aug;20(4):337-42.

> 9. Hjortdal JO, Olsen H, Ehlers N. Prospective randomised study of
> corneal aberrations 1 year after radial keratotomy or photorefractive
> keratectomy. J Refract Surg. 2002 Jan-Feb;18(1):23-9.

> 10. Maguire LJ. Keratorefractive surgery, success, and the public
> health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.

> 11. Uozato H, Guyton DL. Centering Corneal Surgical Procedures. Amer J
> Ophthal. 1987 Mar 15;103(3 Pt 1):264-75.

> 12. Roberts CW, Koester CJ. Optical zone diameters for photorefractive
> corneal surgery. Invest Ophthalmol Vis Sci. 1993 Jun;34(7):2275-81.

> 13. Alster Y, Loewenstein A, Baumwald T, Lipshits I, Lazar M.
> Dapiprazole for patients with night haloes after excimer keratectomy.
> Graefes Arch Clin Exp Ophthalmol. 1996 Aug;234 Suppl 1:S139-41.

> 14. Oliver KM, Hemenger RP, Corbett MC, O'Brart DP, Verma S, Marshall
> J, Tomlinson A. Corneal optical aberrations induced by photorefractive
> keratectomy. J Refract Surg. 1997 May-Jun;13(3):246-54.

> 15. Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina JP,
> Howland HC. Effect of pupillary dilation on corneal optical aberrations
> after photorefractive keratectomy. Arch Ophthalmol. 1998
> Aug;116(:1053-62.

> 16. Holladay JT, Dudeja DR, Chang J. Functional vision and corneal
> changes after laser in situ keratomileusis determined by contrast
> sensitivity, glare testing, and corneal topography. J Cataract Refract
> Surg. 1999 May;25(5):663-9.

> 17. Seiler T, Kaemmerer M, Mierdel P, Krinke HE. Ocular optical
> aberrations after photorefractive keratectomy for myopia and myopic
> astigmatism. Arch Ophthalmol. 2000 Jan;118(1):17-21.

> 18. Schwiegerling J, Snyder RW. Corneal ablation patterns to correct
> for spherical aberration in photorefractive keratectomy. J Cataract
> Refract Surg. 2000 Feb;26(2):214-21.

> 19. Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision
> disturbances after corneal refractive surgery. Surv Ophthalmol. 2002
> Nov-Dec;47(6):533-46.

> 20. Miyata K, Tokunaga T, Nakahara M, Ohtani S, Nejima R, Kiuchi T,
> Kaji Y, Oshika T. R. Residual bed thickness and corneal forward shift
> after laser in situ keratomileusis. J Cataract Refract Surg. 2004
> May;30(5):1067-72.

> 21. Pallikaris IG, Kymionis GD, Astyrakakis NI. Corneal ectasia induced
> by laser in situ keratomileusis. J Cataract Refract Surg. 2001
> Nov;27(11):1796-802.

> 22. Flanagan GW, Binder PS. Precision of flap measurements for laser in
> situ keratomileusis in 4428 eyes. J Refract Surg. 2003
> Mar-Apr;19(2):113-23.

> 23. Lifshitz T, Levy J, Klemperer I, Levinger S. Late bilateral
> keratectasia after LASIK in a low myopic patient. J Refract Surg. 2005
> Sep-Oct;21(5):494-6.

> 24. Kramer TR, Chuckpaiwong V, Dawson DG, L'Hernault N, Grossniklaus
> HE, Edelhauser HF. Pathologic findings in postmortem corneas after
> successful laser in situ keratomileusis. Cornea. 2005 Jan;24(1):92-102.

> 25. Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE,
> Edelhauser HF. Cohesive tensile strength of human LASIK wounds with
> histologic, ultrastructural, and clinical correlations.
> J Refract Surg. 2005 Sep-Oct;21(5):433-45.

> 26. Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late traumatic flap
> dislocations after LASIK. J Refract Surg. 2006 May;22(5):500-4.

> 27. Schein OD, Vitale S, Cassard SD, Steinberg EP. Patient outcomes of
> refractive surgery. The refractive status and vision profile. J
> Cataract Refract Surg. 2001 May;27(5):665-73.

> 28. Garamendi E, Pesudovs K, Elliott DB. Changes in quality of life
> after laser in situ keratomileusis for myopia. J Cataract Refract Surg.
> 2005 Aug;31(:1537-43.

> 29. Kohnen T, Buhren J, Kuhne C, Mirshahi A. Wavefront-guided LASIK
> with the Zyoptix 3.1 system for the correction of myopia and compound
> myopic astigmatism with 1-year followup: clinical outcome and change in
> higher order aberrations. Ophthalmology. 2004;111:2175-2185.

> 30. Brint SF. Higher order aberrations after LASIK for myopia with
> Alcon and Wavelight lasers: a prospective randomized trial. J Refract
> Surg. 2005 Nov-Dec;21(6):S799-803.

> 31. Netto MV, Dupps W Jr, Wilson SE. Wavefront-guided ablation:
> evidence for efficacy compared to traditional ablation. Am J
> Ophthalmol. 2006 Feb;141(2):360-368.

> 32. Stonecipher KG, Dishler JG, Ignacio TS, Binder PS. Transient light
> sensitivity after femtosecond laser flap creation: clinical findings
> and management. J Cataract Refract Surg. 2006 Jan;32(1):91-4.

> 33. Luna JD, Artal MN, Reviglio VE, Pelizzari M, Diaz H, Juarez CP.
> Vitreoretinal alterations following laser in situ keratomileusis:
> clinical and experimental studies. Graefes Arch Clin Exp Ophthalmol.
> 2001 Jul;239(6):416-23.

> 34. Binder PS. Flap dimensions created with the IntraLase FS laser. J
> Cataract Refract Surg. 2004 Jan;30(1):26-32.

> 35. Biser SA, Bloom AH, Donnenfeld ED, Perry HD, Solomon R, Doshi S.
> Flap folds after femtosecond LASIK. Eye Contact Lens. 2003
> Oct;29(4):252-4.

> 36. Chung SH, Roh MI, Park MS, Kong YT, Lee HK, Kim EK. Mycobacterium
> abscessus keratitis after LASIK with IntraLase femtosecond laser.
> Ophthalmologica. 2006;220(4):277-80.

> 37. Kim JY, Kim MJ, Kim TI, Choi HJ, Pak JH, Tchah H. A femtosecond
> laser creates a stronger flap than a mechanical microkeratome. Invest
> Ophthalmol Vis Sci. 2006 Feb;47(2):599-604.

> 38. Ratkay-Traub I, Ferincz IE, Juhasz T, Kurtz RM, Krueger RR. First
> clinical results with the femtosecond neodynium-glass laser in
> refractive surgery. J Refract Surg. 2003 Mar-Apr;19(2):94-103.

> 39. Principe AH, Lin DY, Small KW, Aldave AJ. Macular hemorrhage after
> laser in situ keratomileusis (LASIK) with femtosecond laser flap
> creation. Am J Ophthalmol. 2004 Oct;138(4):657-9.

> 40. Lifshitz T, Levy J, Klemperer I, Levinger S. Anterior chamber gas
> bubbles after corneal flap creation with a femtosecond laser. J
> Cataract Refract Surg. 2005 Nov;31(11):2227-9.

A good read for anyone considering LASIK. Egad!

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