First Custom Ablation Approval for Nearsightedness and Astigmatism

SANTA CLARA, CALIFORNIA – VISX, INCORPORATED (NYSE Symbol: EYE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VISX CustomVue laser vision correction, a procedure that sets a new standard for vision correction, with the potential to enable better vision than contacts or glasses.

The CustomVue procedure tailors a unique correction for each individual. It employs the VISX WaveScan System, a new diagnostic system that captures a "fingerprint" of the eye which is 25 times more precise than what was previously measurable by standard methods. WaveScan evaluates more than nearsightedness, farsightedness, and astigmatism; it captures other, more specific imperfections in each individual's vision. This data is then used to generate an individualized treatment for a CustomVue procedure.

Dr. Robert Maloney, Director of the Maloney Vision Institute and Associate Clinical Professor of Ophthalmology, UCLA School of Medicine, participated in the VISX multi-center clinical study. Dr Maloney stated, "The results from CustomVue procedures are very impressive, with potential for sharper vision and improved night vision over contacts and glasses. There is no question that this technology is a significant step forward in the advancement of laser vision correction."

The VISX clinical study results that were the basis of the Company's FDA approval exceeded all of the FDA required measurements for safe and effective laser vision correction. The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism.

Clinical data presented at the American Society of Cataract and Refractive Surgery 2003 Symposium and Congress in San Francisco showed that at one year following the procedure, all of the follow-up examinations indicated that participants could pass a driving test to drive without glasses or contacts. 94% of the participants could see 20/20 or better and nearly 70% could see better than 20/20 without glasses or contacts. A six-month evaluation of clinical study participants showed that four times as many people were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts.

"Our goal is to continue to introduce new technologies that advance laser vision correction. We are very pleased to be the first on the U.S. market with approval of laser vision correction for both nearsightedness and astigmatism. We are now moving ahead with an FDA approved human clinical study for CustomVue procedures for the treatment of farsightedness," stated Liz Dávila, chairman and chief executive officer of VISX.

About the market for Laser Vision Correction: It is estimated that in the U.S. alone, there are 50 to 60 million people that are good candidates for laser vision correction. The majority of these people require vision correction for myopia and astigmatism.

About VISX: VISX is a worldwide market leader in the design, manufacture, and sale of laser vision correction systems. Ophthalmologists have performed over 5 million procedures using VISX Systems, reducing or eliminating completely the need for contacts or glasses.

The Choice of More Doctors.

VISX invented the technology for laser vision correction more than 15 years ago. Today, VISX is the choice of more eye doctors for their patients. Plus, thousands of eye doctors and their staffs have had laser vision correction themselves, and have trusted their eyes to VISX.

Dr. Miller is proud to offer Laser Vision Correction to qualified candidates, with the assurance that all patients will receive the most reasonable and safest treatment possible. When Dr. Miller's wife (Kathryn M. Miller, MD – one of San Diego’s top ENT surgeons) elected to have Laser Vision Correction in early 1998, Dr. Miller was faced with the decision of finding the best surgeon in town with the best laser in town to perform the surgery. Dr. Miller performed the procedure himself and today his wife sees 20/15 (better than 20/20) in each eye without glasses. At The Eye Center, all patients are treated like family.

The procedure itself takes only seconds under the skilled eye and hands of an experienced surgeon and cornea specialist, like Douglas Miller, MD. To maximize precision, safety and cost savings for the patient, Dr. Miller performs all his LASIK procedures at the San Diego Eye Bank’s new, state-of-the-art laser center.This enables Dr. Miller's patients to achieve excellent results and the highest level of satisfaction.

The VISX laser has FDA approval to treat nearsightedness, farsightedness, and astigmatism. And to use the VISX laser, a doctor must become VISX certified, which requires a thorough certification process. Dr. Miller, himself, became certified immediately after FDA approval was received. That's why more people in the United States have been treated with the "gold-standard' VISX laser than all others combined. Bottom line: VISX is the most trusted laser vision correction company.

VISX received its first U.S. Food and Drug Administration market approval in 1995 and was the first laser manufacturer with approval to treat low, moderate and high myopia, astigmatism, and hyperopia.

Note: VISX, VISX CustomVue, CustomVue, VISX WaveScan, and WaveScan are trademarks of VISX, Incorporated. Dr. Miller has no financial interest in VISX, Inc.

Nineteen percent of refractive surgeons report having had refractive surgery themselves, according to a survey published in the Journal of Cataract and Refractive Surgery last year.

This fact clearly demonstrates that surgeons themselves believe in the safety of LASIK as a means to freedom from corrective eye wear.

KOLOA, Hawaii -- Having a patient sleep for a few hours after LASIK can help rehabilitate the ocular surface and make the experience more comfortable, according to a presentation here.

"It is important to rehabilitate the ocular surface," said Richard L. Lindstom, M.D. "I think the best thing is what I call ‘nap time.’ Tell the patients to go home and sleep. If they go home and sleep for 2 to 3 hours, by the time they wake up, the epithelium has grown across the gutter. Their surface has begun to rehabilitate. They will be more comfortable and seeing well."

After LASIK is performed, significant strain is put on the ocular surface. "We’ve found the thing that enhances healing the best is simply having the patient go home and sleep. So if they can go home and sleep with their eyes closed for 2 to 3 hours, then that allows the ocular surface to recover," Dr. Lindstrom said.

Sleeping allows the epithelium to grow across the gutter where the flap meets the stromal bed, where the microkeratome has disrupted the epithelium. This growth makes the flap secure so that it will not come loose.

"By the time the patients wake up after the nap, they’re comfortable. The foreign body sensation, photophobia and tearing they would have is gone. The surface has a chance to heal, their vision is better and they’re feeling good," he said.

According to Dr. Lindstrom, the idea for the nap after surgery came from experience.

It’s something that we have promoted and we kind of learned about it from experience," he said. "Patients would come back the next day, and some of them would have really good vision, be comfortable and everything was great. Others would come back, and their eyes would be a little sore and they would have some punctate staining. We would ask questions about what they did. The ones who went home and stayed up and watched TV, read a book or used their eyes would be the ones who had sore eyes with blurrier vision and punctate staining on the cornea. The ones that said they just went home and took a nap are the ones who look great. So we started to recommend it."

Years ago Dr. Miller also saw the correlation between patients who took naps immediately following the procedure and their excellent results. Dr. Miller has been recommending ‘nap time’ for the last 4 years to all of his LASIK patients!

Many patients now are seeing ads that seem to offer LASIK for as low as $499 per eye. If price is your only consideration when contemplating something as important as eye surgery, you should at least ask WHAT it is that is truly being offered. LASIK is exciting and relatively new, and it seems that some marketing tactics are designed to take advantage of the public's misperception that "the laser does all the work."

Of course this is not true. A laser, even something as technologically advanced as a computer-controlled excimer laser for refractive eye surgery, is just a tool, and the results will still depend on the accuracy and skill of the surgeon. At The Eye Center, we understand what corners must be cut to offer "discount eye surgery," but refuse to operate that way.

At The Eye Center, your pre- and post-operative care is supplied by Dr. Miller. We do not employ "closers" to boost our surgical volume. Our number one source of new patients continues to be referrals from satisfied patients.

One last thought: Wouldn't you think it rather ridiculous if you saw the same ad in the paper, but instead of "LASIK" they were offering cheap "heart surgery"?!?

Article

Note: Dr. Miller has chosen the San Diego Eye Bank Laser Center as his preferred site to perform LASIK surgery.

March 2003-San Diego: The San Diego Eye Bank Laser Center has received the "S4" upgrade to its Star Excimer Laser from VISX, Inc. In addition, Dr. Miller became the first surgeon there to use the new "blended zone" feature which is designed to improve outcomes by alleviating the possibility of glare at the treatment zone edge.

These improvements mean better outcomes for our patients through new, well-tested technology. Industry leader VISX, Inc.'s Star S4 tracking system requires no dilating drops, and is able to track eye movements in all three dimensions. No better eye tracking system is currently available. (Please see the article above concerning the new WaveScan customized treatments.)

The San Diego Eye Bank is a non-profit organization whose mission is to bring to its community the latest technology. This means ophthalmologists are free to choose the best LASIK system on the market without regard to profitability, and to know it will be expertly maintained by trained personnel. No doctor using the SDEB facility need worry about "cutting costs" or inflating surgical volume to pay for the laser. At SDEB, sterile supplies are never re-used (including surgical blades), and all of Dr. Miller's patients can be sure they are receiving the highest quality LASIK procedure.

The San Diego Eye Bank Excimer Laser Center implemented a policy of providing each patient treated at this facility with an opportunity to grade our facility and staff. We have been very pleased with the results and would like to share them with you.

The questions and results are as follows:

By Arthur M. Louis - SFC

Q: Is the cost of laser eye surgery considered a medical deduction at tax time?

A: Yes, says Internal Revenue Service spokesman Jesse Weller.

"While cosmetic surgery is generally considered nondeductible,'' Weller says, "surgery to correct your eyesight is a legitimate medical expense for tax purposes. It is not considered cosmetic."

Because most elective procedures aren't covered by insurance - you're probably wondering how you're going to pay for it. It's also important to note that many people benefit from using their Flexible Spending Plans at work to cover the cost of their laser vision correction. Please refer to the article about Flexible Spending Plans.

Flexible Spending Plans Save You Money

Thousands of companies offer their employees the opportunity to sign up for a plan that can save them hundreds of dollars a year on child-care and medical bills. These plans are officially known as "flexible spending arrangements" (FSA's), but are sometimes referred to as reimbursement accounts or "flex" plans. Whatever they are called by your employer, FSA's are worth considering if you expect to incur medical expenses that won't be reimbursed by your regular health insurance plan.

Using FSA's to pay out-of-pocket medical costs can yield hundreds of dollars in tax savings. That because any salary set aside in an FSA escapes both income tax and Social Security tax. For most employees, FSA's are the only way to gain a tax break for medical expenses. With medical expenses deductible on income tax returns only to the extent they exceed 7.5 percent of adjusted gross income, relatively few people are ever able to qualify for the itemized medical deduction.

Medical FSA's have become more valuable in recent years as companies have required employees to pick up a growing share of health-care costs. These costs can sometimes be more difficult to predict far in advance. But there are some costs that can be predicted with a high degree of confidence. Medical FSA's can be used to pay annual deductibles, co-payments to physicians, and other expenses not covered under your employer's regular health plan - such as eyeglasses and dental work. It's also possible to predict some major expenses, such as laser vision correction or if your child is scheduled to be fitted for braces.

By Tim Haddock
Investor's Business Daily

You're ready to get your nearsightedness surgically corrected. But with procedures constantly improving, you're not sure if you should wait or got for it.

Here's what you should know before making a decision.

It's estimated that 1 million Americans will shell out $2,000 to $2,500 per eye this year to permanently correct their myopia or hyperopia.

Myopia, or nearsightedness, is a condition in which the curvature of the cornea is too steep, causing the image on the retina to be out of focus. The cure? Flatten the cornea, and the eye can again focus on distant objects.

Exactly how this is achieved differs in each type of refractive surgery. Risks, recovery time and ranges of correction also vary.

Radial keratotomy. In RK, a scalpel makes small incisions in the cornea radiating outward, letting the eye's own pressure reshape the cornea. Downside: It correctly only mild myopia. You risk weaken in or perforating the corcea. As with all eye sugeries, there is a risk of infection.

Laser. The surgeon uses a laser to remove a hair-thin layer from the center of the cornea's suface. Downside: It can result in halos and haze affecting night vision. Also, a starburst effect can make bright lights appear even brighter. Post-surgery discomfort is considerably greater than with more recent techniques.

LASIK. A thin flap is cut in the cornea with a tiny saw blade and pulled back. A laser is used to reshape the cornea beneath the flap. The flap is replaced, and you walk out the door with the vision you always wanted. LASIK is capable of treating much higher levels of nearsightedness than alternatives can.

"I had LASIK done myself two years ago, and I'm a corneal and refractive surgeon," said Dr. Timothy Cavanaugh of Kansas City's Hunkeler Eye Center. "I looked at everything for a long time and waited until I thought the technology was sufficient to achieve what I needed."

But side effects are the same as for other laser surgeries. And there is a small risk that the flap can shift, requiring more surgery. But a more recent version of LASIK greatly reduces most of these side effects.

INTACS. These clear, crescent-shaped inserts are implanted in the periphery of the cornea via a tiny slit. Rather than flatten the eye by removing tissue from the center of the cornea, INTACS accomplish the same task by pushing on the sides of the cornea.

The real selling point is that the procedure is reversible. "There's no tissue removal like with lasers," said Dr. Brian Boxer Wachler, director of the Jules Stein Laser Refractive Center University of California, Los Angeles. "There's no surgery in the center of the eye, the most critical part for vision."

Donwside: If you're worse than 20/400, you'll need more correction than INTACS alone can provide. And it can't correct irregularly shaped corneas.

Toric soft lenses. An alternative to many eye surgeries, they're the only soft lenses available for astigmatism. And they cost only a few hundred dollars per year.

This article has been reprinted from the Navy and Marine Corps Medical News (MEDNEWS). MEDNEWS is a weekly compendium of news and information contributed by commands throughout the Navy Medical department and distributed by the Navy Bureau of Medicine and Surgery (BUMED). Information contained in MEDNEWS stories is not necessarily endorsed by BUMED, nor should it be considered official Navy policy.

NOTE: VISX Excimer Laser Systems are used exclusively by the Navy for laser vision correction.

ABOARD USS ABRAHAM LINCOLN (CVN 72), AT SEA -- For most USS Abraham Lincoln (CVN 72) sailors, May 17 was a day like any other. But for Lt. Cmdr. Kevin Mannix, an F/A-18 Hornet pilot for VFA-25 on board Abe, the day was very special.

Mannix became the first pilot with laser corrected vision to land his plane aboard an aircraft carrier. Vision is a major player in sailors' day to day lives on board Abe, and no one knows that more than the Navy's fighter pilots. Their vision is the most important sense they have, and for some of our most skilled pilots, that sense is degrading fast. For years, Mannix has been plagued with deteriorating vision, having to wear different pairs of eyeglasses for different purposes.

That was the case until just six weeks ago when Mannix received laser corrective eye surgery. "My vision was normally around 20/100, but by the time I got the surgery, I was at about 20/200," Mannix said. "Six weeks later, my vision is better than perfect at 20/12. The requirement to get the surgery done is to have vision worse than 20/50, so I more than qualified."

Following the three-hour-plus exam, doctors concluded that Mannix could go ahead with the surgery. "The hardest part about the whole thing was the exam. It seemed like it lasted forever," Mannix said. "The actual surgery itself lasted about 20 minutes."

The doctor who performed the procedure for Mannix was Lt. Cmdr. David Tanzer, MC, an optical specialist and refractive surgeon at Navy Medical Center in San Diego. What I basically do is sit the patient down, and we go through it all," said Tanzer. "I run a slew of different tests on the patients, looking at every possible problem they have with their eyes, and then we base the surgery on the results."

One thing that all service members need to know is that this treatment is available to all active-duty personnel. "There's a waiting list," Tanzer said. "Depending on your job, you could wait anywhere from three months to well over three years before receiving the surgery. However, if you can wait, it could save you about $5,000 in all or about $2,500 per eye."

Mannix said that he wished everyone could have the procedure performed. "I'm ecstatic about the results," he said. "I'm seeing things that I've never seen before, and it's amazing. Contrast and definition are enhanced; my peripheral vision is perfect. It almost seems like my sight is unlimited."

The only real problem with the whole process, according to Mannix, is he had 30 days of down time before he was able to fly again. “Being able to come in and trap on the flight deck again was a great feeling," Mannix said. "It's been a while since I've been able to do that, and I think I did pretty well."

Mannix also has an acquaintance in the world of corrective surgery. Capt. Douglas Dupouy, commanding officer of Abraham Lincoln, has also received the treatment. In fact, Dupouy was the patient directly after Mannix. Now that some of the Navy's finest pilots are receiving such treatment, it's possible for the Navy to retain their time and experience in the cockpit, right where it belongs.

-USN-

San Francisco -- The California Department of Health told LaserVue Eye Centers in March to notify 2,700 laser in-situ keratomileusis (LASIK) patients that their surgeons rinsed and reused microkeratome blades and handpieces instead of sterilizing them.

A NOTE TO MY PATIENTS (from DR. MILLER): This news item clearly demonstrates why one should avoid discount "assembly-line" LASIK mills. Despite the obvious reasons of unfamiliarity between the patient and surgeon, risk of error by numerous technicians, impersonal treatment, and rushed atmosphere, one must also question where the cost savings are coming from.

In this instance, the doctor allegedly re-used LASIK blades to save time and money, putting patients’ safety at risk for infection and poor visual results. At THE EYE CENTER, all of your pre- and post-operative care is performed personally by me. We have NEVER re-used any disposable LASIK materials, and ALWAYS use a new keratome blade FOR EACH EYE. Over the last year, 90% of our patients have elected to have Intralase, the blade-free method of LASIK flap creation, thereby avoiding this issue altogether.

Yes, this does make the procedure somewhat more expensive, but ask yourself this: Do you REALLY want the cheapest eye surgery in town?!?

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