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    Posted April 23, 2009 by
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    Saturday April 25th Marks the One Year Anniversay of the FDA Hearings on LASIK


    This Saturday will mark the One Year Anniversary of the April 25th LASIK hearings held by the FDA.


    What has been accomplished since those hearings to inform the public about the true nature of the severe risks of LASIK surgery?

    LASIK poses a serious public health risk and a signifacant danger to the financial well beaing of our nation! At the present time, there is no technology that will restore a patient's post-LASIK vision loss to the same quality experienced before undrgoing LASIK surgery.  Post-LASIK patients who are no longer able to work leads to additional costs to the US Treasury in the form of disability payment, and a loss of revenues fro formerly income tax-paying individuals.

    At that hearing. LASIK patients with severe adverse effects, psychologists, doctors, concerned citizens, and parents of LASIK patients whose children have committed suicide due to the alarming and disturbing visual aberrations that were induced by the surgery testified before the committee. All of the transcripts and videos from the FDA hearing are available at http://www.lasikfda.com. What came out of the hearings was worse than nothing.

    The FDA created a “Joint LASIK Study Task Force” to perform a Post-LASIK Quality of Life study that was conducted by the very doctors who perform LASIK surgery and own LASIK centers. In early April they released their findings if their report which proclaimed the following conclusion: “Based on this review, worldwide, an average 95.4% of patients were satisfied with their outcome after LASIK surgery. With 16.3 million procedures performed worldwide, and more than a decade of clinical studies and technological innovation, LASIK surgery should be considered among the most successful elective procedures. LASIK surgery compares more favorably with other elective surgical procedures in terms of generally higher satisfaction rates.” Upon carefull review, the full report clearly reveals how bogus this statement is, and how methodology to reach these conclusions illistrates the obvious bias of the Joint Task Force to misrepresent the true risks of LASIK to the public, the FDA, and congress.

    Please note that there was not a single sociologist, psychologist, psychiatrist, or other non LASIK industry insider on the task force.

    Also note that If you review the Financial Disclosure section you will find that all the task force members are LASIK doctors and their students who have a clear vested interest in seeing that LASIK remains seen in a positive light by the general public, when it is in fact a threat to the public health.


    About the report:

    The Joint LASIK Study Task Force narrowed down the number of articles used in the "global literature review" from 2915 to only 19 studies representing 2,198 patients (a mere 0.01% of LASIK patient worldwide assuming 16.3 million procedures have been performed as per their statements.).

    Of the 19 studies used for the analysis, only 6 report complication rates in the abstract. The article states: "Although this database also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life." They chose not to report the complication rates. So what exactly does “quality of life” mean?

    Follow-up ranged from 1 month to 5 years. Sixteen of the nineteen studies used non-validated questionnaires. If a patient was "somewhat satisfied", that counted as "satisfied".

    The article states: "Of note, poor quality of life scores after refractive surgery were associated with regression, dry eye, poor vision in low light, and halos at night."  This is exactly what the LASIK patient community has been saying.  So why exactly does the FDA need further study of LASIK dissatisfaction? And why isn't the FDA paying any attention at all to the 500-plus LASIK adverse events that were filed through MedWatch in 2008, which show that dry eyes and poor night vision are the chief complaints?

    It also states: "This review showed that LASIK surgery can influence one’s quality of life. However, this statement is based in 2 articles that were identified in the world literature review." They are as follows: The first author is Kerry Solomon, and the next 7 authors appear to work with or for Dr. Solomon at Storm Eye Institute. The remaining two authors are Eric Donnenfeld and Richard Lindstrom. It appears the majority of the number crunching took place at Solomon's Storm Eye. After the authors names it says "for the Joint LASIK Study Task Force".


    Ophthalmology. 2003 Jul;110(7):1371-8. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Bailey MD, Mitchell GL, Dhaliwal DK, Boxer Wachler BS, Zadnik K.


    Halos were reported by 30%, glare by 27%, and starbursts by 25% of all subjects.


    J Cataract Refract Surg. 2005 Oct;31(10):1943-51. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM.


    Glare from oncoming car headlights after surgery was reported by 58.4% and was believed to be more bothersome for night driving than before surgery by 52.8%.


    J Fr Ophtalmol. 2004 Sep;27(7):755-64. [Lasik, PRK and quality of vision: a study of prognostic factors and a satisfaction survey][Article in French] Saragoussi D, Saragoussi JJ.


    Daytime vision was the same or better for 91.1% of the patients, but 25.6% had worse night vision than before. Night vision symptoms were mentioned by 46.7% of the patients, and the most frequent complaint was halos.


    J Cataract Refract Surg. 2000 Apr;26(4):497-509. Functional, psychological, and satisfaction outcomes of laser in situ keratomileusis for high myopia. McGhee CN, Craig JP, Sachdev N, Weed KH, Brown AD.


    Most patients (81% to 100%) reported functional improvement across the spectrum of visual tasks assessed, although 8.8% reported difficulty with nighttime driving.


    J Refract Surg. 2002 Jul-Aug;18(4):454-9. An informal satisfaction survey of 200 patients after laser in situ keratomileusis. Hill JC.


    Night vision was not a problem or was unchanged from baseline in 76% of patients; 24% said they were worse; 17% said their symptoms were better.


    CLAO J. 2001 Apr;27(2):84-8. Patient satisfaction after LASIK for myopia. Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH.


    Twenty-nine percent reported reduced night vision clarity following LASIK and 27% noted more eye dryness following LASIK.


    Can anybody guess why the authors didn't report the complication rates?

    The Joint LASIK Study Task Force Members were disclosed at the end of the article: Richard L. Abbott, MD, Flora Lum, MD, Samuel Masket, MD, Jennifer Morse, MD, Terrence P. O’Brien, MD, Konrad Pesudovs, OD, PhD, Steven C. Schallhorn, MD, Heather, M. Skeens, MD.

    The financial disclosure is the most interesting aspect of this literature review to me as it clearly illistrates complete conflicts of interest:

    Financial Disclosure(s):

    Kerry D. Solomon is a consultant for Alcon Laboratories, Inc., Allergan, Inc., Advanced Medical Optics, Advanced Vision Research, Bausch & Lomb, Incorporated, Eyemaginations, Inc., and QLT.

    Eric D. Donnenfeld is a consultant for Alcon Laboratories, Inc., Allergan, Inc., Advanced Medical Optics, Advanced Vision Research, Bausch & Lomb, Incorporated, Eyemaginations, Inc., Pfizer, QLT, TLC, and Wavetec.

    Richard L. Lindstrom is a consultant for AcuFocus Inc, Advanced Medical Optics, Advanced Refractive Technologies, Alcon Laboratories, AVS, Bausch and Lomb, Inc, BioSyntrx, Clarity Ophthalmics, Clear Sight, CoDa Therapeutics, EBV Partners, Egg Factory, Encore, Eyemaginations, Inc, Glaukos Corporation, High Performance Optics, Improve Your Vision, I-Therapeutix, Lensar, LenSX, S.V.L. Sciences, Midwest Surgical Services, Minnesota Eye Consultants, P.A., Neurovision, NuLens, OccuLogix, Ocular Surgery News/Slack, Omeros Corporation, Pixel Optics, Quest, Refractec, RXVP, Supply Eye, 3-D Vision Systems, TCL Vision, Tracey Technologies, Versant, and Vision Solutions Technologies.

    I am seeking an immediate moratorium on the use of excimer lasers for LASIK surgery as there has never been a clinical trial to support the safety guideline of less than 1.0% occurrence of adverse events required by the Food and Drug Administration (FDA) for approval.


    The abstract of the LASIK World Literature Review - Quality of Life and Patient Satisfaction can be found at: http://www.ophsource.org/periodicals/ophtha/article/PIIS0161642008013377/abstract

    I do not have the legal right to attach the copy which I published from Ophsource.

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