レーシック指標医師の一分/ウェブリブログ

レーシック指標

<< 作成日時： 2008/04/25 01:26 >>

　レーシック指標と呼ばれる。
　景気の下降で消費者は支出を削減するのに比例して、角膜屈折矯正レーザー治療が減少している。2007年に80万人以上の米国人がレーシック治療を受けたが、景気後退と共に2008年は17%の低下を予測されている。一般に、800～3000ドル以上の治療費がかかる。
　豊胸手術やボトックス治療も影響を受けているという。ボトックスの場合は、治療中の人が間隔を延ばすということはないが、新規の治療は減るだろう。しかし、レーシック治療が最も影響がありそうだ。
　経済的な理由以外にも、効果や副作用の点からの影響もあると思われる。重大な眼の障害や数年で視力改善が元にもどるといった問題が出てきているという。
　1995年に認可されて以来、米国で1200万人が治療を受けたが、不幸な結果となった患者の数は着実に増加しており、注目されている。
　副作用は1%以下で極めて低いといわれているが、夜間の視力やコントラストの問題はQOLに関連するものなので、今まできちんとした研究がなされてこなかった。
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As Economy Slows, So Do Laser Eye Surgeries
By BARNABY J. FEDER　　Published: April 23, 2008
http://www.nytimes.com/2008/04/23/business/23lasik-web.html?_r=1&ref=health&oref=slogin

Call it the Lasik indicator. As the economic downturn forces consumers to cut back on discretionary spending, laser vision-correction surgeries have been falling ― as they did during the last recession.

Although more than 800,000 Americans got Lasik surgery in 2007, a slight increase from 2006, the numbers started slumping along with the economy in the second half of last year. And industry analysts are now seeing a Lasik recession.

“We’re forecasting a 17 percent drop for 2008,” said David Harmon, president of Market Scope, an eye surgery market research house.

Mr. Harmon said that when first-quarter data become available next month, he expects it to show an even sharper decline in Lasik surgeries than in 2001, when the sour economy triggered a three-year slump in the laser procedures, which are typically not covered by insurance.

Lasik ― for laser-assisted in situ keratomileusis ― typically costs anywhere from $800 to $3,000 or more an eye.

Mr. Harmon’s forecast is based on the relatively strong correlation in recent years between Lasik procedures and the Conference Board’s index of consumer confidence in the economy.

Doctors and analysts said a wide range of elective medical procedures, including breast implants and skin treatments like Botox injections, are also being affected.

“People are just being a little more conservative about their finances,” said Dr. Robert Cykiert, a New York ophthalmologist who does both eye surgery and Botox injections.

In the case of Botox, for example, Dr. Cykiert’s existing patients are not spacing out their treatments but some who are interested have been hesitant to start, he said.

So far, though, Lasik procedures are the most evidently affected.

Still uncertain is the extent to which, beyond economic considerations, the Lasik downturn may also reflect the growing number of complaints about poor results from the procedures. Federal regulators have received reports about dry eyes, double vision and distorted night vision, among other things. And numerous blog sites carry sobering tales of more serious eye damage or cases where vision improvements seemed to disappear within a few years.

Those concerns will be reviewed Friday at a meeting of the Food and Drug Administration’s advisory board on ophthalmic devices. The panel is also expected to consider proposing a major new study on Lasik outcomes.

The F.D.A. is also asking the panel to suggest ways to get more doctors, patients and hospitals to report problems stemming from laser surgery or lens implants. One goal cited in documents the agency published Wednesday is to gather more Lasik data through SightNet, an online network of ophthalmologists who are voluntarily linked to the agency’s Medical Product Safety Network.

Lasik involves cutting a flap in the surface of the cornea to gain access to the central portion of that natural lens, which is then reshaped by the laser. Lasik can reduce or in many cases eliminate nearsightedness, far-sightedness and astigmatism.

Lasik practitioners say a recent analysis of past studies showed 95 percent satisfaction rates, regardless of whether the data is arranged to compare patients in the United States to overseas, procedures before and after 2000, short-term or long-term results or anonymous versus identified patients. But with 12 million patients having undergone the procedure in the United States since 1995 when it was first approved, the sheer number of individuals with unhappy outcomes is growing steadily, and more of their stories are gaining public attention.

“My eyes are damaged beyond repair,” Pamela C. Barncastle, 62, of Albuquerque, N.M., said in a phone interview. Mrs. Barncastle said she underwent the surgery in 2001 but now suffers double vision, as well as seeing halos and spikey bursts of blurred light at night that prevent her from driving then.

She said she needed to undergo a corneal transplant, which would be paid for by a settlement with her doctor. But she said that for now she is living with her vision problems because she is the sole caregiver for her father and her husband, an Alzheimer’s patient.

Mrs. Barncastle said she was also worried about the large number of Lasik patients she has talked to who seem to be developing cataracts. “There needs to be a lot more monitoring of the industry and studies of the long-term effects,” she said.

Publicity about the complaints being aired at the F.D.A. panel hearing Friday could hit the shares of Advanced Medical Optics, which gets just over a third of its revenue from the sale of lasers and related gear used in the surgery, said Lawrence Biegelsen, a medical device analyst for Wachovia Capital Markets.

The growing attention to unhappy Lasik outcomes is also bad news for companies that operate chains of laser surgery centers, like LCA-Vision and TLC Vision, which have already seen their stocks pummeled by declines in procedure at the end of last year that they attributed to the economy.

No immediate action is expected from the F.D.A. In the last year, the agency has been working with the National Eye Institute, American Society of Cataract & Refractive Surgeons, and American Academy of Ophthalmology to design a trial that will track patients who undergo Lasik or get implanted contact lenses. Most past studies have focused on the degree of vision correction attained and medical complications like infection rather than everyday vision issues like night vision and contrast that can affect quality of life.

Medical complications are now below 1 percent, an all-time low, according to Dr. Kerry Solomon, the co-chairman of the committee trying to develop the study design. “But there haven’t been a lot of good quality of life studies,” said Dr. Solomon, who is a professor of ophthalmology at the Medical University of South Carolina.

One result of the study might be to further clarify which patients are not good candidates for Lasik, he said.

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FDA : LASIK Eye Surgery
http://www.fda.gov/cdrh/lasik/
Learning about LASIK
(Image from animation, showing laser beam reshaping the cornea during LASIK procedure.)
• View movie of the LASIK procedure.
(Requires Flash Player - Download now)
• Read text descriptions of the LASIK movie

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery. See other sections of this site to learn about what you should know before surgery, what will happen during the surgery, and what you should expect after surgery. There is a glossary of terms and a checklist of issues for you to consider, practices to follow, and questions to ask your doctor before undergoing LASIK surgery.

LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser. A mechanical microkeratome (a blade device) or a laser keratome (a laser device) is used to cut a flap in the cornea. A hinge is left at one end of this flap. The flap is folded back revealing the stroma, the middlesection of the cornea. Pulses from a computer-controlled laser vaporize a portion of the stroma and the flap is replaced. There are other techniques and many new terms related to LASIK that you may hear about.
Updated March 6, 2008

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LASIK Surgery Checklist
http://www.fda.gov/cdrh/lasik/reduce.htm
Know what makes you a poor candidate

* Career impact - does your job prohibit refractive surgery?
* Cost - can you really afford this procedure?
* Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?
* Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?
* Medications - do you take steroids or other drugs that might prevent healing?
* Stable refraction - has your prescription changed in the last year?
* High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?
* Pupil size - are your pupils extra large in dim conditions?
* Corneal thickness - do you have thin corneas?
* Tear production - do you have dry eyes?

Know all the risks and procedure limitations

* Overtreatment or undertreatment - are you willing and able to have more than one surgery to get the desired result?
* May still need reading glasses - do you have presbyopia?
* Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
* May permanently lose vision - do you know some patients may lose some vision or experience blindness?
* Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
* Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
* Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
* Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
* Patient information - have you read the patient information booklet about the laser being used for your procedure?

Know how to find the right doctor

* Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
* Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
* Informative - is your doctor willing to spend the time to answer all your questions?
* Long-term Care - does your doctor encourage follow-up and management of you as a patient? Your preop and postop care may be provided by a doctor other than the surgeon.
* Be Comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?

Know preoperative, operative, and postoperative expectations

* No contact lenses prior to evaluation and surgery - can you go for an extended period of time without wearing contact lenses?
* Have a thorough exam - have you arranged not to drive or work after the exam?
* Read and understand the informed consent - has your doctor given you an informed consent form to take home and answered all your questions?
* No makeup before surgery - can you go 24-36 hours without makeup prior to surgery?
* Arrange for transportation - can someone drive you home after surgery?
* Plan to take a few days to recover - can you take time off to take it easy for a couple of days if necessary?
* Expect not to see clearly for a few days - do you know you will not see clearly immediately?
* Know sights, smells, sounds of surgery - has your doctor made you feel comfortable with the actual steps of the procedure?
* Be prepared to take drops/medications- are you willing and able to put drops in your eyes at regular intervals?
* Be prepared to wear an eye shield - do you know you need to protect the eye for a period of time after surgery to avoid injury?
* Expect some pain/discomfort - do you know how much pain to expect?
* Know when to seek help - do you understand what problems could occur and when to seek medical intervention?
* Know when to expect your vision to stop changing - are you aware that final results could take months?
* Make sure your refraction is stable before any further surgery - if you don't get the desired result, do you know not to have an enhancement until the prescription stops changing?

Updated July 12, 2007

(Some Photos Copyright © 2000, Photodisc, Inc.)
(Some Photos Copyright © 2000, Photodisc, Inc.)