Press Lasik Eye News

  • A Clearer View Of The World
    An in-depth article from from the Washington Times on the benefits of LASIK.
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  • Navy Medicine Takes First Step With LASIK for Aviators
    Navy Medicine Takes First Step With LASIK for Aviators
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  • Wall Street Journal - Lens Makers
    Eye Treatment using ReZoom, ReStor and Crystalens Technologies
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  • STAAR Surgical Announces First Myopia
    Treatment Using the VISIAN ICL(TM).
    Read Full Story

  • Laser provides accuracy, reproducibility of flap thickness
    Technology developed for previously denied LASIK candidates.
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  • Lens implant improves vision
    FDA approved Verisyse lens corrects moderate to bad eyesight.
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  • Implanted lens approved for nearsightedness
    Alternative to laser surgery could be available soon.
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  • FDA Approves Lens Implant to Sharpen Sight
    Lens implants provide alternate solution to glasses.
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  • Patients in Cincinnati Now Able to Receive First-Ever Accomodating Intraocular Lens
    Wednesday, June 30, 2004
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  • Goodbye Reading Glasses - New, Five-Minute Procedure Could Make Reading Glasses Obsolete
    Monday, April 12, 2004
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  • To Read the Menu, Baby Boomers Turn to Eye Treatments
    Sunday, April 11, 2004
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  • Two Breakthroughs in Cataract Surgery Now Available at The MidWest EyeCenter
    Wednesday, April 7, 2004
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  • MidWest EyeCenter offers the First and only FDA-approved Vision Technology for Presbyopic Baby Boomers.
    Tuesday, March 23, 2004
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  • Refractec Gets FDA Approval For Its Presbyopia Treatment
    Monday, March 22, 2004
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  • New procedure gives hope to people with cataracts, other eye trouble
    Wednesday, January 28, 2004
    By Lila Lazurus
    Special to The Detroit News
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  • Staying Focused
    LASIK Eye Surgery Helps Golfers See Game More Clearly
    Read Full Story

  • Vision For Helping Others
    Wednesday January 5, 2000
    By Alisha Woolery
    Community Press Newspapers
    Read Full Story

  • Schneider Recognized by VISX, Inc. For Laser Surgery Skill
    Thursday, May 14, 1998
    The Clermont Sun
    Read Full Story

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  • 98 percent of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated;

  • 87 percent of patients could see 20/20 in the distance and also read J3 or phonebook-sized print (significantly smaller than news print) when using both eyes.

  • There were NO reported serious, sight-threatening or unanticipated safety events.


    • "Many patients who have had CK tell us it's the best thing they've ever done for themselves," added Dr. Sanitato.

    About NearVision CK

    NearVision CK is performed using a probe thinner than a strand of hair that releases radiofrequency energy. Applied to the cornea in a circular pattern, the radio waves shrink small areas of collagen to create a constrictive band (like the tightening of a belt) that increases the curvature of the cornea, bringing near vision back into focus.

    NearVision CK is indicated for the temporary improvement of near vision in emmetropic presbyopes (those who require only reading glasses) and hyperopic

    presbyopes (those who require reading and distance glasses). The procedure is typically performed on just one eye, improving near vision without compromising the patient's binocular distance vision.

      Refractec Gets FDA Approval For Its Presbyopia Treatment

    Refractec Inc. is set to announce today that it has received Food and Drug Administration approval to market a procedure that uses radio frequency energy to treat presbyopia, the close-vision problem that afflicts nearly everyone by age 50.

    The procedure, Conductive Keratoplasty, known as CK, uses radio waves to reshape the cornea and bring near vision back into focus. Refractec plans to market CK as a safe and painless surgery that doesn't require any cutting or removal of tissue. It can be performed in only a few minutes in a doctor's office.

    Presbyopia results from the hardening of the eye's lens with advancing age, a problem that forces middle-age people to rely on reading glasses to order from a restaurant menu or check their watch. Refractec, a closely held 10-year-old company in Irvine, Calif., estimates that 90 million baby boomers either have the condition or will develop it over the next 10 years.

    The procedure costs patients between $1,500 and $2,000 per eye. It is typically performed in just one eye, restoring close-up vision without compromising distance vision.

    Daniel S. Durrie, a refractive surgeon in Overland Park, Kan., and lead investigator on the studies reviewed by the FDA, said 30,000 procedures have been performed over the past five years without any safety problems. "This is the first FDA approval for a surgical treatment for presbyopia," he added.

    Dr. Durrie, a paid consultant to Refractec, cautions that not every baby boomer is a candidate for CK, especially people with thin corneas. Some people won't be totally freed from their reading glasses after the surgery. Patients may need additional treatments as they grow older and their vision continues to deteriorate. "We can turn the clock back, but we can't keep it from ticking," he said.

    Two years ago, Refractec won FDA approval to market CK for farsightedness, or hyperopia, a less common condition than presbyopia. Once a procedure is approved for a specific procedure, physicians are allowed to use it "off label" for other indications and many refractive surgeons have been performing CK on their presbyopic patients.

    The latest FDA approval is important because it allows Refractec and independent surgeons who own its technology to begin marketing CK for presbyopia.

    The technology, including training, requires about a $50,000 investment by the surgeon.

    The procedure is performed using a probe thinner than a human hair that releases radiofrequency energy. The radio waves are applied in a circular pattern to shrink small areas of corneal tissue. The treatment pattern acts like a belt tightening around the cornea, increasing its curvature to bring near vision back into focus.

      Staying Focused


    LASIK Eye Surgery Helps Golfers See Game More Clearly

    Professional golfers Tom Kite, Fred Funk, and Julie Inkster all have one thing in common when it comes to improving their golf game, a new surgical procedure called LASIK (Laser Assisted In-Situ Keratomileusis). LASIK is a relatively new surgical technique used to correct patients suffering from myopia (nearsightedness) and astigmatism. In the case of Tom Kite, it corrected his vision from 20/1000, and perhaps the thickest lenses on tour, to 20/15, comparable to the eyes of a fighter pilot. In the tri-state area, LASIK has been performed for a number of years. Recently we had the opportunity to sit down with Molly Rutledge, lasik counselor for MidWest EyeCenter, to talk about the procedure and the effect it has had on the many people it has helped.

    TSGolf: Molly, please explain in laymen terms what exactly LASIK surgery entails.

    MR: Before we get into how the surgery is performed, I think we need to review how the eye works. Remember in your health classes, you were taught how the eye functions on much the same principles as a camera? The iris, or colored portion, acts as a shutter, regulating the amount of light admitted to the eye. The cornea (the clear window at the front of the eye) and the lens located behind the pupil, focus the light rays onto the retina in the back of the eye. From the retina, the image viewed is transmitted to the brain where it is seen.

    If the light rays entering the eye are focused in front of the retina instead of directly on it, as in a normal eye, you have a condition called myopia or nearsightedness. People with myopia see objects close to them more clearly, and far objects appear blurry or even indistinguishable.

    If the light rays entering are focused behind the retina instead of directly on it, you have a condition called hyperopia or farsightedness. People with hyperopia have difficulty seeing things in the distance or near unless they wear some type of optical correction.

    The other quite common condition is astigmatism. Astigmatism occurs when the curve of the cornea is uneven, not entirely spherical in shape. This irregularity causes a doubling or ghosting effect of the object focused on.

    TSGolf: Does the LASIK surgery correct all three conditions?

    MR: Right now, the surgery only corrects myopia (nearsightedness) and astigmatism. The FDA is about to approve the surgical technique to correct hyperopia and we should be performing surgery within the next month and a half.

    TSGolf: Great! How does LASIK work?

    MR: In nearsightedness the cornea is too steep and must be resculped to its proper shape. The eye is numbed with eye drops and a lid speculum gently holds the eye open. With an instrument that the doctor controls completely, an extremely thin, hinged flap is cut in the corneal tissue. The flap is pulled back to expose the underlying layer for treatment with the laser. The laser produces a beam of ultraviolet light in pulses that last only a few billionths of a second. Each pulse removes a microscopic amount of tissue, evaporating it. This method eliminates the "haze reaction" that was sometimes a side effect of the old PRK procedure. The entire surgery takes approximately 10-15 minutes, but the use of the laser usually lasts less then one minute.

    TSGolf: Cool, but let's ask the big question ... Does it hurt?

    MR: I can honestly tell you there is very little, if any discomfort associated with the procedure.

    TSGolf: That's what they all say!

    MR: But I really can, you see, I’ve had the surgery myself.

    TSGolf: How long did it take you to heal and is the surgery permanent?

    MR: As soon as the doctor is finished using the laser the comeal flap is replaced and actually adheres to itself, often referred to by Dr Schneider, the center's director, as 'nature's Velcro'. It heals practically instantly and then you need about two to three days of taking it easy on your eyes. The correction is likely to be permanent because we are permanently removing a fine layer of the corneal tissue.

    TSGolf: What's the best part about having the surgery?

    MR: I wore glasses most of my life and have experienced all the problems that go with it...dirt or sweat on the lenses, lost and broken glasses, etc. Like many people, I could never wear contact lenses because of the sensitivity of my eyes. The freedom I now have in all aspects of life, and especially in any type of physical activity, has allowed me to experience opportunities that were less attractive before the surgery. It's great!

    TSGolf: I read where the director of MidWest EyeCenter, Dr. David M. Schneider, was recently recognized as one of the nation's top 50 LASIK surgeons. Is the procedure gaining in popularity in the tri-state?

    MR: Since first performing the laser surgery in 1995, Dr Schneider has performed over 20,000 laser surgeries to correct nearsightedness and astigmatism. He has treated local and national celebrities including former Cincinnati Bengal Cris Collinsworth, and radio disk jockeys Mark "Ranger Bob" Erickson of 92.5 and Charlie "Wild" Hackett of Mix 94.1. In addition, he has performed LASIK on a growing number of area physicians and celebrities.

    TSGolf: Thanks Molly for the insight on the amazing LASIK procedure.

    If you would like more information on LASIK surgery, you can contact MidWest EyeCenter at 513-752-5700, or visit their website at www.midwesteyecenter.com.

      Vision For Helping Others


    Wednesday January 5, 2000 By Alisha Woolery
    Community Press Newspapers

    It is early in the morning when Bogdon Korolyuk steps into Dr. David Schneider’s office in Eastgate on Wednesday, December 15.

    He is nervous about the surgery to remove the cataract from his right eye. Like most 11-year-olds, Bogdon does not like needles. Unfortunately, he has had more experience with pain than most children.

    Last winter Bogdon wandered into an abandoned chicken farm outside his village in Ukraine, and was shocked by a 10,000-volt wire. According to a local Ukrainian newspaper, the children who were with Bogdon during the accident said he "lit up" from the charge. His injuries were extensive. A portion of his skull was damaged severely, he lost his right arm, suffered major burns and internal injuries and had a traumatic cataract form on his right eye.

    His mother, Vera, a milkmaid, took Bogdon to a city for medical treatment, but the facilities were limited, as were the family’s finances. The newspaper article said that Vera, and many other workers in their village, had not been paid a salary in more than a year.

    A group of missionaries from Calvary Chapel in Glendale heard about Bogdon, and the small congregation sponsored a trip to Cincinnati and the medical expertise at Children’s Hospital Medical Center, Shriners Hospital and Dr. Schneider, an eye surgeon with MidWest EyeCenter.

    Calvary Chapel Pastor Ed Gaines said he felt impressed by God to help Bogdon. The boy and his mother are living with church members during Bogdon’s treatment and recovery in Hebron, KY. Gaines has been coordinating efforts between all of the doctors treating Bogdon, and was the representative who contacted Dr. Schneider about the child’s eye condition.

    "We were looking for someone who would allow us to pay in installments," Gaines said.

    But Dr. Schneider had a different idea. He called Gaines back immediately and offered his surgical services for free.

    "I’ve been blessed," Schneider said, when asked why he decided to help Bogdon. "If a person is a doctor and dedicated to healing people… how could somebody not want to help this child? That’s what our profession is all about."

    Gaines describes Bogdon as "bright and intelligent, with a great sense of humor." His faith has kept him from losing the tenderness of a child, Gaines said. Dr. Schneider had met Bogdon several times and added that his enthusiasm is catching.

    "He brings a lot to our lives through his positive attitude," Schneider said.

    The operation to remove Bogdon’s cataract is the most advanced in the world, Schneider said. The procedure involves making a microscopic slit in Bogdon’s eye at the base of the iris (colored portion of the eye), then inserting a tool inside the slit emitting sound waves. This breaks up the cataract, and the instrument then removes the cataract’s fragments.

    After the brief surgery, Bogdon’s eye was free of the milky covering which robbed him of his sight for the past year. It was one more step in healing Bogdon. He has already had 17 other surgeries for his injuries.

    Pastor Gaines hopes to have prosthesis for Bogdon’s missing arm by Christmas, and by spring Bogdon should have a bone graft from his rib cage to cover the hole in his skull. The family will probably stay in the U.S. for another two years to complete Bogdon’s treatment, Gaines said.

      Schneider Recognized by VISX, Inc. For Laser Surgery Skill


    The Clermont Sun
    Thursday, May 14, 1998

    Dr. David M. Schneider, director of the MidWest EyeCenter at Eastgate was recognized recently by VISX, Inc. as one of the nation's top 50 refractive laser surgeons. Schneider has been performing refractive surgery since his first Radial Keratotomy procedure in 1980, and has performed nearly 4,200 laser eye surgeries to correct nearsightedness and astigmatism since April 1996.

    According to Shareef Mahdavi, director of marketing for the Santa Clara, Ca.-based VISX, Inc. laser systems, Schneider has been, awarded the designation of "VISX Star" surgeon. Under this designation, according to Mahdavi, Schneider officially represents the elite surgeons who performed the most laser vision correction procedures on VISX systems.

    "This a wonderful milestone in my long career as a refractive surgeon," Schneider said, "To be recognized for one's professional achievements is very gratifying, but what I'm most proud of is the results we are getting for our patients."

    He continued, "Watching people literally get rid of their glasses and contacts lenses overnight fills both me and my patients with a deep sense of gratitude and joy. Oftentimes, both of us are sharing tears of joy at the miracle of new sight."Since his entrance into the world of performing refractive laser surgery in 1995, Schneider has surgically treated local and national celebrities including former Cincinnati Bengals star/recent TV sports analyst Emmy Award winner Cris Collinsworth, and radio disc jockeys Mark "Ranger Bob" Erickson of 92.5 FM and Jim LaBarbara of 103.5 FM. In addition to his celebrity patient list, Schneider has had the privilege of performing LASIK on a growing number of doctors.

    According to Molly Rutledge, LASIK counselor for MidWest EyeCenter, "What it all typically comes down to when a patient is considering LASIK, is 'Who has the most experience, who should I trust my eyes to?' And that's understandable."

    She added. "We feel we are able to provide to Cincinnati patients and patients around the nation for that matter, the highest possible quality of vision corrective surgery with Dr. Schneider. The fact that he has performed refractive surgery on patients from all 48 continental states as well as 19 foreign countries, tells our patients how much demand there is for his services."


     

    Lens Makers
    Hawk Implants
    In Ad Campaign
    By RHONDA L. RUNDLE October 20, 2006;

    Page B1

    Seven days before the Masters Golf Tournament in April, 70-year-old Gary Player had an artificial lens, called the ReZoom, implanted in his left eye. In the first round, the hall-of-fame golfer birdied the first hole, which he attributes largely to his sharpened vision. A month later, he had the surgery in his right eye.

    Information travels fast in the medical technology world. Mr. Player now is the paid spokesman at the center of a consumer-marketing campaign that lens maker Advanced Medical Optics Inc. has created for ReZoom. The campaign includes a package of TV, radio and print ads that eye surgeons can pay to run in local media. About 1,000 doctors are participating, the Santa Ana, Calif., company says.

    The campaign makes Mr. Player the most visible pitchman yet for a product -- multifocal lens implants -- that should be a marketing shoo-in. Sales of these new lenses, which received Food and Drug Administration approval last year, represent a big improvement for cataract patients over standard, monofocal lenses. Implanted in cataract surgery, they correct patients' vision both at a distance and at close range; standard lenses in most cases require patients to wear reading glasses after cataract surgery.

    But sales of multifocal lenses have been lackluster, despite approval from many patients who use them. The problem is the price tag: For patients 65 and older, the federal Medicare insurance program covers nearly all the cost of cataract surgery using standard lens implants. Cataract surgery using the new lenses usually sets patients back $3,400 to $5,000 out of pocket.

    That's where the advertising comes in. ReZoom's rival, the ReStor lens from Alcon Laboratories Inc., of Switzerland, has its own consumer advertising push, including a safari-themed TV commercial being tested in some markets starting this week. The ad campaigns are a departure in health-care marketing because they employ a marketing tactic usually reserved for elective treatments to sell a procedure that isn't elective.

    Multifocal lens implants at present are something of a luxury -- an add-on to a necessary procedure. But the potential future market for the technology is huge. There were about 2.8 million cataract surgeries performed in the U.S. last year, making it one of the nation's most common procedures.

    The new ads clearly target people who can afford to pay. For example, Alcon's campaign for ReStor lenses shows a handsome, white-haired woman and her young grandson on what appears to be a private safari. Grandma, sitting in a vehicle with guidebook in hand, spots elephants, giraffes and other game in the distance. Naturally, she isn't wearing glasses.

    The need for reading glasses typically emerges when people enter their 40s, when the natural lens loses its ability to focus. Cataracts, which affect most people by the time they enter their 70s, cause a blurring of the eye's natural lens. Multifocal lenses correct both problems, but they aren't a guaranteed fix. A small percentage of people may continue to need glasses occasionally for close work or night-time driving.

    Multifocal lens makers got a boost in May 2005 when Medicare changed its rules so that surgeons could charge patients for the difference between the cost of conventional cataract surgery using older lenses and a similar procedure using the new ones. Previously, surgeons weren't allowed to charge extra for upgraded lenses or the additional time that is usually required to fit and adjust them.

    "One of the big challenges is that suddenly a physician is put in a situation where he had to introduce this wonderful technology, but then had to explain that it is substantially more expensive -- making it a much more difficult conversation," says Michael Rutstein, director of consumer health care at Interpublic Group 's DraftFCB, the New York ad agency that created the Alcon campaign. The goal of the ad campaign, he says, is to educate cataract patients so they understand they have a choice of lenses and are "presold" on multifocals when they arrive in the surgeon's office.

    Earlier this year, DraftFCB sent a couple of strategic planners for a weekend at a Florida senior community to peer into residents' lives. The seniors weren't doing a lot of knitting and crossword puzzles. The agency people found the seniors had plenty of disposable income, they didn't see themselves as old, and they had "tremendous passion to take on the next chapter of life," Mr. Rutstein says. "Sight was life for a lot of people," he says. The insights inspired the safari campaign, which is meant to resonate with a demographic group the agency calls "the roaring matures."

    The campaign began running Monday in six markets in Texas, North Carolina, Florida and Michigan -- geographic regions where Alcon has concentrations of ophthalmologists using the ReStor lens. Print ads are appearing in seniors-oriented magazines, local newspapers and Parade magazine and USA Weekend. Alcon may expand the campaign nationally next year, says Stuart Raetzman, vice president and general manager of the cataract surgical business. He declined to discuss the budget.

    Clay Wilemon, president and founder of DevicePharm Inc., the Irvine, Calif., agency that created the Gary Player campaign for ReZoom lenses, says multifocal marketers have learned lessons from the market for lasik, the elective surgery that uses lasers to shave the cornea and correct distance vision, usually in younger patients who are myopic. In the lasik market, he says, the most effective ads have linked consumers directly to doctors -- "taking the manufacturer out of the loop," Mr. Wilemon says. Among the markets where surgeons are running the ads are Seattle; San Diego; Phoenix; Dallas; Chicago; Cincinnati and markets in Florida and South Carolina.

    David Schneider, an ophthalmologist with four Cincinnati-area offices, has started running the ReZoom commercials in local air time during programming including "Oprah" and "Today" and on CNN. He has added footage of his MidWest EyeCenters to the end of the spots. A small number of patients in their 50s, who don't yet have cataracts, have paid $10,000 out of their own pockets for multifocal lenses, Dr. Schneider says. Dr. Schneider says he is keen on ReZoom but also uses ReStor and Crystalens, a third entrant in the category, made by Eyeonics Inc., of Aliso Viejo, Calif.

    Mr. Player says he had "magnificent" eyes until he was 50. Starting five years ago, he says he could no longer see a golf ball when it landed on the fairway, even when wearing his contact lenses. As his cataracts gradually worsened, he found it difficult to select the right club out of his bag, to see oncoming cars or to enjoy the beauty of his horse ranch in South Africa. Finally, he overcame his longtime fear of cataract surgery and went under the knife. Now, he says, "I can see a grasshopper winking at me."

    Write to Rhonda L. Rundle at rhonda.rundle@wsj.com

     

    A Clearer View Of The World
    Tuesday, October 30, 2007 Washington Times

    Darin Brown has a new outlook on life. Last month, the 44-year-old Germantown resident underwent LASIK eye surgery.
    Before the surgery, Mr. Brown often found himself misplacing his glasses or turning his contacts inside out. The LASIK procedure has allowed him to see clearly without either of them.
    "I can see so much better now," Mr. Brown says. "There is a sharpness. When I'm driving at night, I can see farther. I saw a live deer about 100 yards ahead while driving. I might not have seen him before."
    The LASIK procedure has advanced so much that NASA approved the technology for U.S. astronauts last month. The LASIK, or laser-assisted in situ keratomileusis, technology also has been endorsed for U.S. military personnel.
    When NASA approved LASIK for astronauts, it only confirmed what Dr. Mark Whitten says he already knew. "This is one more confirmation," he says. "If NASA will allow astronauts to have this done to them, the person with everyday activities will be fine."
    Dr. Whitten is regional medical director of TLC Laser Eye Centers of the metro D.C. area. The company has offices in Rockville, Reston and McLean. Mr. Brown is his patient.
    Athletes have known for years that LASIK is effective, Dr. Whitten says. He has lasered athletes such as golfer Tiger Woods.
    "They look at all of this technology as performance enhancement," Dr. Whitten says. "They see better. They perform better. For the average person, they might not notice all the little things the athletes see."
    The new all-laser LASIK procedure helped convince NASA of its safety and effectiveness, says Dr. Steve Schallhorn, chief medical director for Optical Express in Glasgow, Scotland. He also has a private practice in San Diego.
    Although Dr. Schallhorn retired from the U.S. Navy in February, he previously served as its director of refractive surgery, where he conducted about 200 studies on laser vision correction. He also has been a consultant to NASA.
    While conventional LASIK uses a hand-held microkeratome blade to create a corneal flap, the newer form of LASIK uses a femtosecond laser. The laser is computer guided and eliminates several of the possible complications associated with the mechanical blade.
    "The femtosecond laser was a totally different way to make a flap," Dr. Schallhorn says. "We found it resulted in a better flap."
    During the second step of the new procedure, wavefront guided technology maps a patient's eye using another type of laser. Then it corrects the problems that are specific to the person's eye, he says. In the conventional procedure, the laser essentially follows the general prescription used for measuring glasses or contact lenses. The new technology is about 25 times more precise, he says.
    The combination of the femtosecond laser and wavefront-guided treatment to correct refractive error has produced optimal results, Dr. Schallhorn says. Advanced Medical Optics Inc., the Santa Ana, Calif., company that helped to pioneer the technology, calls it "Advanced CustomVue with IntraLase." The procedure is about four years old.
    While working for the Navy, Dr. Schallhorn also ran a series of studies that looked at the effects of the environment on LASIK patients. For instance, he tested the stability of the corneal flap in high altitudes and how it would respond during a wind blast or sudden ejection from an aircraft.
    "We basically found that when you do a good LASIK procedure that there are no additional environmental risks other than what the general public should have," Dr. Schallhorn says. "If LASIK is

     

    STAAR Surgical Announces First Myopia Treatment Using the VISIAN ICL(TM)

    • STAAR Surgical VISIAN ICL Offers Adults a Minimally Invasive Alternative for Correction of Nearsightedness
    • First Procedure in U.S. After Clinical Trials; Patient's Eyesight Improved From Inability to See Largest Letter on Vision Chart to 'Better than 20/20'

    MONROVIA, Calif., Jan. 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), today announced that the first VISIAN ICL(TM) (Implantable Collamer Lens) has been surgically implanted in the U.S. since the Food and Drug Administration approved the premarket approval application for the lens in December 2005. Dr. John Vukich, ophthalmic surgeon and medical director at the Davis Duehr Dean Medical Center in Madison, Wisconsin, performed the procedure on January 10, 2006, which resulted in a dramatic improvement in the patient's vision. The patient had previously only been able to count fingers when placed one foot in front of her. Dr. Vukich reported that post-operatively her vision was "better than 20/20."

    The VISIAN ICL is the only foldable, minimally invasive lens approved for the correction of myopia, or nearsightedness, in adults.

    During the six-minute, topical anesthetic procedure, Dr. Vukich made a micro incision to allow positioning of the implant behind the iris, or the colored part of the eye. "The 36-year old female patient had -9.5 diopters of myopia before the procedure and was unable to see the largest letter on the standard vision chart," said Dr. Vukich. "Post-operatively, the patient was able to see letters smaller than the 20/20 visual acuity would allow. She showed significant improvement instantaneously, and within one hour following the procedure was able to see better than 20/20 without eyeglasses."

    "Immediately after the ICL procedure, the patient sat up and read the time off the clock across the room," added Dr. Vukich. "The VISIAN ICL is an exciting technological advancement and it will allow a great number of individuals suffering from nearsightedness to enjoy clear vision without glasses. The ICL has been shown to be a safe, minimally invasive procedure that has produced outstanding clinical outcomes, and it is a significant improvement to the ophthalmic surgeon's arsenal."

    The Company indicated that Stephen Slade, M.D., in Houston, Texas; David Schneider, M.D. in Cincinnati, Ohio; and Paul Dougherty, M.D., in Los Angeles, California, would also be performing VISIAN ICL surgeries this week. STAAR cautions that individual patient results will vary. Not all patients will achieve 20/20 vision or better.

    About the VISIAN ICL

    Made of a highly biocompatible Collamer(R) material containing a small amount of collagen, the VISIAN ICL's unique lens design allows for an incision 50% smaller than competing technology and for a more aesthetically pleasing outcome, because the lens is placed behind the iris. The procedure is also reversible, as the lens can be removed without permanently altering the structure of the eye.

    Currently, more than 860 surgeons in the U.S. have completed the first phase of training toward becoming certified to conduct the procedure. Doctors familiar with the technology have noted the ICL's stability, the safety of the procedure, superior clinical outcomes and high patient satisfaction rate. In addition to the U.S., the ICL is approved for sale in 41 countries (including the European Union) and has been successfully implanted in more than 40,000 eyes worldwide.

    The VISIAN ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from -3.0 to less than or equal to -15.0 diopters, with astigmatism less than or equal to 2.5 diopters at the spectacle plane, and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation. The safety and effectiveness of the VISIAN ICL is not established for patients who fall outside these requirements. Additional information on the safety and effectiveness of the VISIAN ICL will be available on the FDA website at www.fda.gov/cdrh/pdf3/p030016.html.

    About STAAR Surgical

    STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the revolutionary VISIAN ICL as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's ICL has received CE Marking, is approved for sale in 41 countries and has been implanted in more than 40,000 eyes worldwide. More information is available at www.staar.com.

    Safe Harbor

    All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements regarding expectations for success of the ICL in U.S. or international markets, statements of belief and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include our limited capital resources and limited access to financing, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and our ability to successfully launch and market the ICL in the U.S. while overcoming the foregoing challenges. Our ability to capitalize on the opportunity presented by the ICL approval depends on our overall financial condition, which can be adversely affected by our ability to implement our cost savings strategies and realize our expected savings, our ability to reverse the decline in domestic sales of intraocular lenses, our ability to maintain or enhance our existing product sales and gross profit margin and reduce compliance expenditures, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, and other factors beyond our control, including those detailed from time to time in our reports filed with the Securities and Exchange Commission. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

     
    Patients in Cincinnati Now Able to Receive First-Ever Accomodating Intraocular Lens
    Newly FDA-Approved CrystalensTM Restores Up Close, Far Away and Everything-In-Between-Vision

    Cincinnati, OH – (June 30, 2004) – CrystalensTM, the first and only accommodating intraocular lens that allows patients to focus automatically and seamlessly at all distances, is now available in the Greater Cincinnati area. David M. Schneider, MD at the MidWest EyeCenter, one of less than 150 ophthalmic and refractive surgeons nationwide authorized to perform this procedure, is now evaluating patients who are interested in receiving this lens. The Crystalens received FDA approval on November 14, 2003.

    “Crystalens is a revolutionary new breakthrough in vision enhancement,” said J. Andy Corley, chairman and CEO, Eyeonics Inc. “It is an intraocular lens replacement that accommodates like the eye’s natural lens, allowing for seamless focusing up close, far away and at all distances in between, giving patients their best possible vision seamlessly.” The ability to provide patients with clear vision at all distances is a significant technological breakthrough in the competitive field of intraocular lens technology. “Unlike standard IOLs, the Crystalens restores vision at all distances and in most cases eliminates the need for glasses and contacts for everyday tasks. Giving people the ability to focus at all distances is a singular advantage over all current cataract procedures,” Corley stated. “Approval of the Crystalens has been anticipated by ophthalmic and refractive surgeons throughout the U.S. who are eager to offer this first-of-its kind option to their patients,” Corley said.

    How the Crystalens Works
    The Crystalens is the result of more than 14 years of research and development by J. Stuart Cumming, MD, F.A.C.S., and Chief Scientific Officer of Eyeonics, Inc. Early on in his research Cumming noted that the ciliary muscle in the eye did not stop functioning in older patients. Therefore he created a lens that works by moving in a backwards and forwards motion along the axis of the eye in response to pressure changes in the front and back of the eye that result from relaxation and contraction of the ciliary muscle. This muscle inside the eye is responsible for focusing the eye in younger patients. As a result, patients experience the same vision they had when they were younger, for most without the inconvenience of corrective lenses. In contrast, standard intraocular lenses only restore distance vision – therefore patients may still require glasses or contacts to see up close and all points in between.

    “Most people don’t realize how much vision occurs at arm’s length and at in-between distances,” said Dr. Cumming. “In between vision means you can sit at your computer, read a magazine or engage in a hobby, even use a golf scorecard, in most cases without corrective lenses, seamlessly,” he said.

    “This lens brings us one step closer to the eyes we were born with,” said David Schneider, MD, a leading ophthalmic surgeon in Cincinnati. “Crystalens helps the patients to look their best and to experience a freedom and empowerment that will allow them to feel their best.”

    For more information or to determine if Crystalens is the right vision correction solution for you, please call the MidWest EyeCenter at (513) 752-5700.

    About Eyeonics, Inc.
    Eyeonics, Inc., a venture-backed medical device company headquartered in Aliso Viejo, California, was founded in 1998 by J. Andy Corley, Chairman and CEO and J. Stuart Cumming, MD, Chief Scientific Officer, Crystalens developer and cataract surgeon for over 25 years. Eyeonics has received 25 patents with 51 pending. Worldwide more than 6,000 lenses have been implanted to date.

      Goodbye Reading Glasses

    New, Five-Minute Procedure Could Make Reading Glasses Obsolete.

    There's a new, minimally invasive medical procedure that can allow people to get rid of their eyeglasses, especially reading glasses.

    Conductive Keratoplasty, or "CK," was approved by the Food and Drug Administration in February, 2004, to correct the most common eye problem affecting Americans: the blurred reading vision that begins when most people hit baby boomer age.

    Larry Winkleman, 48, of Fullerton, Calif., was an ideal candidate for the procedure. He had excellent vision growing up but several years ago he discovered he needed glasses to read. Then he found even distance vision was blurred. So he was left constantly juggling two pairs of glasses.

    "I'm switching glasses constantly and they're getting tangled up," he told ABCNEWS minutes before undergoing CK. "I take them off my head and they fall on the ground. For me, it doesn't work."

    Contact lenses were not an option for Winkleman because of the dust at his family's print shop. And the idea of surgery, even laser surgery, made him uneasy. "I was not able to reconcile myself to cutting my cornea. It didn't set right with me," he said.

    But Winkleman was eager to try the CK procedure.

    "CK is not a laser. No tissue is removed. There is no cutting," said Dr. Penny Asbell, an ophthalmologist at Mount Sinai School of Medicine in New York and a clinical investigator of CK.

    "CK is a procedure that allows [patients] to have their cake and eat it too. They end up with great vision, not needing glasses, not needing contact lenses with a relatively low risk, minimally invasive procedure," said Dr. Asbell. Compared to Lasik surgery, she said: "It's less risky. That's the real advantage."

    Quick, Minimally Invasive Procedure

    During the five-minute CK procedure, doctors insert a metal fiber, the width of a hair, along the edge of the cornea. Radio waves then heat the cornea, which shrinks and reshapes the tissue, correcting the patient's vision.

    According to data presented to the FDA, after the procedure, 98 percent of patients could read magazines and newspapers without glasses, while 87 percent could read even finer print, such as a telephone book, without glasses.

    The CK procedure has only been tested for about four years so no one is certain how long the effect will last or whether there are any long-term complications. The most immediate side effect patients report is a sense of "scratchy" or "watery" eyes, which is usually gone within 24 to 48 hours.

    CK costs as much as Lasik surgery, at about $1,500 to $2,000 an eye.

    Doctors emphasize that CK is not for people who have the type of eye problems that require glasses early in life. Those patients would be candidates for LASIK surgery, which flattens the cornea to correct nearsightedness.

    CK is an option for people whose vision deteriorated in mid-life and who found they had to hold the newspaper farther and farther away as their reading vision became increasingly blurry.

    Most patients only require the procedure on one eye. But Winkleman had it done on both eyes to improve reading vision in one eye and distance vision in the other. Immediately afterward, he could see an improvement in both. "This is great," he said. "The glasses are gone!"

      To Read the Menu, Baby Boomers Turn to Eye Treatments

    A few months ago, George Miller, 55, a computer sales manager in Lexington, S.C., had reading glasses scattered all over the house. Worse, he found it was impossible to read a menu at night in a dimly lighted restaurant or the many car magazines that came to his house. "It really bothered me a lot because I love to read," Mr. Miller said. So, when he heard about a new experimental eye surgery on the local television news, he researched it on the Internet and called his ophthalmologist.

    "I'm a little vain," Mr. Miller conceded. Though the new procedure, which uses radio waves to correct near-vision problems, had not yet been approved by the Food and Drug Administration for his problem, he had it done last winter.

    "It was a no-brainer," said Mr. Miller, who no longer needs reading glasses. "I can't imagine why anyone who could afford it would not do it."

    Biology and vanity are collaborating to make vision correction techniques a boom market, as some 78 million aging Americans seem intent on seeing well but looking good. Granny glasses? Grandpa's bifocals? Not for them. Offer them the option of paying $1,500 for a three-minute remedy and the eyeglasses are gone.

    "The baby boomers are kind of a picky bunch," said David Harmon, president of MarketScope, an eye care market research company in Baldwin, Mo., near St. Louis. "They want to be fixed."

    Last month, the FDA approved the latest surgical procedure, called Conductive Keratoplasty (CK) to correct a common near-vision problem for people whose eyesight is otherwise excellent, in a minimally invasive way.

    Unlike LASIK, the popular laser surgery, conductive keratoplasty procedures do not involve using lasers to change the shape of the eye. Instead, a tiny instrument applies radio waves in a circular pattern on the outer cornea, shrinking small areas of collagen, a fibrous protein found in connective tissue, bone and cartilage. The treatment increases the cornea's curvature, improving near vision.

    In the last few years, about three million people, as many as 5 percent of Americans with vision problems, have opted for LASIK surgery to correct nearsightedness, farsightedness and astigmatism. In LASIK, the surgeon cuts and pulls a flap in the cornea and then uses a laser to reshape the underlying tissue at a cost of up to $1,600 an eye. Neither LASIK nor CK is covered by most insurance plans.

    The latest procedure is only one of an array of new vision therapies, recently introduced or in late stages of development. They include improvements that make laser surgery machines more accurate and eliminate the knife blade typically used to prepare the eye, as well as a dozen new types of lens implants.

    One new artificial lens mimics a healthy 20-year-old's ability to see at both near and far distances. Others eliminate harmful high-spectrum blue light, reducing the need for sunglasses.

    William Link, a California scientist and entrepreneur who helped start several eye care companies, estimates that established companies like Alcon Laboratories, Bausch & Lomb and VISX have spent a total of $750 million in the last five years developing products for the baby boomers. In addition, Mr. Link says, he and other venture capitalists have contributed more than $140 million to companies like Refractec, the start-up based in Irvine, Calif., that developed conductive keratoplasty.

    The company teaches eye surgeons to do the procedure and sells them the machines for about $58,000, compared with about $325,000 for laser machines.

    Conductive keratoplasty was approved by the FDA for hyperopia, a less common vision problem, two years ago. After 30,000 cases, an agency panel of 12 experts unanimously recommended it for near-vision problems, and it received approval March 16.

    Conductive keratoplasty is usually performed on one eye only. The other eye provides most of the distance vision, and the mind coordinates the visual information as it does for people who naturally have one farsighted eye and one nearsighted eye. Even so, if the patient's prescription requires treatment in both eyes, it can be done on the same day.

    Ophthalmologists say the corrective effects may weaken after five years or so, but the procedure is too new for them to be sure. An FDA panel said patients should be warned that the treatment "may affect depth perception," which could be a driving hazard. The panel also recommended to the full agency that there be information in the label about a relatively few patients who ended up with astigmatism after the procedure.

    Dr. Penny A. Asbell, an ophthalmologist at the Mount Sinai School of Medicine in New York, recalled that a patient who works with younger colleagues in the music industry also wanted the procedure even before it was approved. "He didn't want to be the only one at the table putting on reading glasses to read a contract," Dr. Asbell said. "Everybody else there is hip-hop, or whatever they do," she said.

    Ophthalmologists say they find that many middle-aged patients are conservative about trying risky eye operations. An estimated 1 in 10 LASIK patients needed a repeat treatment until the technology was improved. The FDA warns on its web site that the procedure is not for everyone.

    Last year, Alcon, which says it has 30 percent of the market for eye surgery in the United States, received approval in the European Community for a new intraocular lens implant for cataract patients that enhances close-up and distance viewing. The procedure has not yet been priced in the United States, the company said. These new lenses may cost as much as $600 each.

    Although the company expects FDA approval in 2005 for United States cataract patients, who are typically in their late 60's and 70's, the new multifocal lenses will probably attract some younger patients willing to pay for the implants. The new lens will also protect against blue light, eliminating dependence on sunglasses after the operation. "Also, they won't need a cataract operation later on," Bill Barton, an Alcon vice president, said.

    Mr. Barton said tests with cells in the laboratory suggested that blue light might be a "causative factor" in macular degeneration, the leading cause of blindness in older Americans.

    Alcon is also testing a prescription drug that is intended to stop or prevent changes in the eye that lead to macular degeneration. Bausch & Lomb is doing early stage research on a continuous drug delivery system at the back of the eye implant to combat the disease.

    Despite all of the advances, millions of Americans will hold fast to their eyeglasses. After all, it might not have been as funny to watch Jack Nicholson and Diane Keaton using their vision problems (along with Viagra jokes) to illustrate advancing age in the comedy movie "Something's Gotta Give."

    Still, for people who are over 40 and start having trouble reading, the message from the eye industry is clear: there are more options than ever.

    Mr. Link, a managing director of Versant Ventures, a venture capitalist firm in Menlo Park, Calif., turns 58 today. He had the conductive keratoplasty procedure last year and was rewarded as a fly fisherman. "Now I can tie the flies on my line without reading glasses," he said.

      Two Breakthroughs in Cataract Surgery Now Available at The MidWest EyeCenter

    New IOL from Alcon Approximates Eye's Natural Blue Light Filtering Capability

    Novel Removal Procedure Uses Fluid to Gently "Wash Away" Clouded Lenses

    Cincinnati, OH, April 7, 2004 - Two revolutionary advances in cataract surgery became available the latter part of 2003. Surgeons at the MidWest EyeCenter are among the first in the United States to make these products available to their patients.

    A cataract is a clouding of the eye's lens that can cause vision problems. Cataract surgery involves removing the cloudy lens and replacing it with an artificial lens.

    The first advance, Alcon's AcrySof Natural, received approval by the U.S. Food and Drug Administration (FDA) and is the world's first foldable intraocular lens (IOL) that is specifically designed to filter high-energy wavelengths of the blue light spectrum for cataract surgery patients. Alcon's Infiniti™ Vision System, the second advance, is a new surgical lens removal instrument that offers the option to use a naturally balanced fluid media to break up and "wash away" the eye's lens when it becomes clouded by cataracts.

    In a normal eye, light passes through the lens and gets focused on the retina. To help produce a sharp image, the lens must remain clear. In its early stages, a cataract may not cause a vision problem and cloudiness may affect only a small part of the lens. Over time, the cataract may grow larger and cloud more of the lens, making it harder to see and oftentimes requiring surgery.

    Until the availability of the AcrySof Natural Lens, IOLs were less effective than the eye's natural ability to filter blue light. The new AcrySof Natural IOL approximates the natural blue light filtering capability of the human lens.

    "A growing body of evidence shows high frequency blue light may lead to retinal damage," said David M. Schneider, M.D. "The AcrySof Natural IOL filters this potentially dangerous blue light without negative visual consequences."

    Age-Related Macular Degeneration (AMD) is a degeneration of the macula, the eye's most light-sensitive region of the retina. The disease impacts central vision and may limit the ability to read, drive and perform other activities that require fine, sharp vision.

    Research suggests blue light may be one of the risk factors in causing the progression of AMD. AMD is one of the leading causes of blindness in the developed world.

    However, the long-term effects of filtering blue light and the clinical efficacy of that filtering on the retina have not been conclusively established.

    "With this new intraocular lens and novel cataract removal system, we will be better able to offer patients the improved quality of life afforded by cataract surgery, plus the potential benefit of filtering blue light," James J. Sanitato, M.D. said. "This is an important advance for patients undergoing cataract surgery."

    The Infiniti Vision System is the world's first tri-modal lens removal surgical instrument. With this single instrument, surgeons may choose the most appropriate of three different methods based on the individual patient's situation to remove a cataract:

  • A completely new lens removal method, called the AquaLase®* Liquefaction Device, uses pulsed surgical solution to safely break up and remove the natural lens material. This method represents the first departure from the industry standard for almost 20 years, and is only available with the Alcon Infiniti Vision System. It breaks up the clouded lens with pulses of warm, naturally balanced solution to "wash away" the lens. The new technology may reduce the risk of thermal burns and other potential complications.
  • Industry leading, advanced ultrasound phacoemulsification, also is an option with the Infiniti Vision System. With this method, a metal probe vibrating at ultrasound frequency is used to soften and break up the lens. The Infiniti Vision System features an improved ultrasound handpiece that makes it easier for surgeons to hold and control.
  • A third method uses both ultrasound and oscillation to help break up the cataract faster, and may allow the surgeon greater control of lens tissue than traditional ultrasound

    • Scientists think there may be several reasons for the development of cataracts; including aging, smoking, diabetes and excessive exposure to sunlight. Cataracts can also develop soon after an eye injury, or even years later. The most common type of cataract is related to aging and more than half of all Americans age 65 and older have a cataract. Cataracts affect men and women equally, as well as all races and ethnic groups.

    "Everyone at the MidWest EyeCenter is excited about the AcrySof Natural IOL," said David M. Schneider, M.D. "We are committed to providing our patients with the best care available and believe these products will enhance our ability to do that."

    "The AcrySof Natural lens and Infiniti Vision System are being adopted by many ophthalmic practices across the United States," said Cary Rayment, Senior Vice President, Alcon United States. "We believe surgeons are eager to use AcrySof, with its unique capability to filter blue light, and Infiniti, as an entirely new surgical platform, and their enthusiasm will make a difference for countless patients with cataracts."

      David Schneider, M.D. and James Sanitato, M.D. of the MidWest EyeCenter lead Cincinnati, Ohio/Northern Kentucky to offer the First and only FDA-approved Vision Technology for Presbyopic Baby Boomers.
  • NearVision CK (Conductive Keratoplasty) is the Sole Procedure for the Millions Who Want Freedom from Reading Glasses.

  • America's Most Prevalent Eye Condition: 90 Million Have or Will Soon Develop Presbyopia.

    • Cincinnati, Ohio/ Northern Kentucky - March 23, 2004 - MidWest EyeCenter today announced that David Schneider, M.D. and James Sanitato, M.D. are among the first ophthalmologists in the Cincinnati and Northern Kentucky area to offer the NearVisionSM CK® (Conductive Keratoplasty®) procedure, performed with the ViewPoint™ CK System. Just approved by the U.S. Food and Drug Administration (FDA), it is the first and only FDA-approved vision technology that improves near vision in the millions of baby boomers with presbyopia, the age-related eye condition that sets in after age 40. NearVision CK uses radio waves to reshape the cornea and bring near vision back into focus. Minimally invasive and painless, NearVision CK is performed in less than three minutes in the doctor's office with only eye-drop anesthesia. The procedure is laser-free and extremely safe; there is no cutting and no removal of tissue. Both doctors have been performing NearVision CK since August 2003.

    The Greek word for "aging eye," presbyopia is the most prevalent eye condition in America, affecting most people after age 40 and everyone by age 51. Presbyopia causes near vision to fade with age, making it difficult to see things up-close. An estimated 90 million baby boomers either have presbyopia or will develop the condition in the next 10 years. These people struggle to read or do hobby work and must rely on magnifying reading glasses for even the most mundane of daily tasks, like checking their watch. They often own multiple pairs of reading glasses (called "readers," "half-eyes" or "granny glasses"), which many consider a hassle and an unwelcome sign of aging.

    "Presbyopia is the one inescapable vision disorder that will eventually affect us all," said Dr. David Schneider. "The frustration many people feel with the on-again, off-again annoyance of reading glasses cannot be overemphasized. NearVision CK is just what tri-state baby boomers have been waiting for to help them safely reduce their dependence on reading glasses."

    NearVision CK / Page 2 of 2

    Procedure Custom-Made For Baby Boomers

    NearVision CK is the only vision procedure designed specifically for baby boomers who want a safe, minimally invasive procedure to free them of reading glasses. CK has become the fastest-growing new refractive procedure since the introduction of LASIK according to research firm Market Scope. More than 30,000 CK procedures have been performed since the FDA first approved it in 2002 for age-related farsightedness (hyperopia), a condition that differs from presbyopia in its effect on the eye's ability to focus, but has similar symptoms.

    The FDA based its approval on clinical trial data collected at the 12-month follow-up visit in which NearVision CK demonstrated effectiveness in significantly improving patients' near vision.