News on LASIK and Other Refractive Eye Surgery

WASHINGTON, April 2008 — Visual function as measured by what's seen on an eye chart is one way of determining success following a LASIK surgery procedure.

But the U.S. Food and Drug Administration (FDA) wants to clarify whether LASIK actually improves quality of life.

To do this, the agency will undertake a major study in 2009 in cooperation with the National Eye Institute, American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.

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The study will assess quality of life following LASIK based on factors such as general satisfaction beyond how eyesight is traditionally assessed.

Between 1998 and 2006, the FDA reported receiving 140 comments from people unhappy with the outcomes of LASIK procedures.

FAIRFAX, Va., March 2008 — About 95 percent of the more than 16.3 million people worldwide who have undergone LASIK eye surgery are satisfied with their results, according to the American Society of Cataract and Refractive Surgery (ASCRS).

"We find that there is solid evidence in the world's scientific literature to affirm that there is an exceptionally high level of satisfaction in patients who have had LASIK surgery," said ASCRS president Richard L. Lindstrom, MD.

ASCRS based its conclusions on a review of nearly 3,000 peer-reviewed articles appearing in scientific and medical journals worldwide.

Lindstrom acknowledged that risks are still involved and some outcomes are unfavorable, which is why eye surgeons continually seek to improve technology and techniques.

Researchers who reviewed scientific literature said successful outcomes also involve selecting appropriate candidates for LASIK based on factors such as eye health.

BOSTON, March 2008 — People who don't produce enough tears could be poor candidates for LASIK eye surgery, according to Schepens Eye Research Institute scientists.

Researchers identified specific low levels of tear production that could be linked to dry eye problems following LASIK. As part of the Schirmer eye test for dry eye, scientists found tear production was inadequate for LASIK at levels of less than 20 mm of moisture produced on a paper test strip during a five-minute period.

Scientists said this lower tear production level could be used as criteria for identifying people who need treatment for dry eye in advance of LASIK. In some cases of low tear production, individuals may be eliminated altogether as candidates.

Study results were published in the January issue of Investigative Ophthalmology and Vision Science.

WASHINGTON, October 2007 — Aspiring astronauts who have undergone "all laser" LASIK can now be considered for NASA's space program because of a recent policy change.

Previously, LASIK was considered unsafe for astronauts in extreme conditions such as liftoff because of a hinged flap created on the eye's surface. After the cornea is reshaped by an excimer laser, the flap is replaced as a type of natural bandage.

Healing times are much faster because of the flap used with LASIK. But NASA officials feared that even a healed flap could become dislodged under extreme conditions.

Now, NASA officials say that modern wavefront-guided LASIK using flaps created by a special laser (femtosecond) known as IntraLase has a safety profile good enough to clear the vision correction procedure for astronauts.

KLEINOSTHEIM, Germany, September 2007 — Schwind company officials say they have introduced a new "high performance" excimer laser that shortens times for procedures such as LASIK. Built-in features of the new laser include continuous measurements of the eye's surface (corneal) thickness.

Schwind officials say the new excimer laser can reshape an eye at the rate of less than 2.5 seconds per diopter of correction. An eye tracker that helps keep the laser beam on target has a response time of approximately three milliseconds.

The new excimer laser, known as Amaris, was unveiled in September at the European Society of Cataract and Refractive Surgeons (ESCRS) conference in Stockholm.

WASHINGTON D.C., July 2007 — The U.S. Food and Drug Administration has announced approval of a common corrective eye surgery technique, known as monovision LASIK, in which one eye is corrected for near vision and the other eye is corrected for distance.

The LASIK procedure often is used off label for correcting presbyopia, the age-related inability to focus at all distances. But the recent FDA action for the first time officially approves use of the monovision technique with a specific excimer laser, the Advanced Medical Optics (AMO) and Visx CustomVue.

As follow-up, FDA officials say they also have asked AMO and Visx to conduct a six-month study evaluating visual outcomes and quality-of-life issues for 500 individuals who have undergone monovision LASIK.

CHICAGO, April 2007 — Older individuals undergoing LASIK can achieve positive outcomes, along with a good safety profile, says a University of Illinois at Chicago study.

Adjustments were made in vision corrections to compensate for differences in the way the eye's clear front surface (cornea) heals in people 40 or older, said investigator and study co-author Dimitri Azar, MD.

"We are seeing an increasing demand for LASIK surgery for older adults, who present special challenges," Azar said.

The study involved 710 consecutive laser eye surgeries in 424 people between 40 and 69. In all groups studied, 91 percent to 97 percent achieved 20/40 uncorrected vision for nearsightedness or farsightedness.

But Azar said presbyopia, which affects near vision in older people, is a special problem. One solution is monovision, when one eye is corrected for near vision and the other for distance.

STERLING, Va., April 2007 — A new U.S. Food and Drug Administration approval means WaveLight's Allegretto Wave Eye-Q excimer laser system for wavefront-guided LASIK and other procedures now can be used to treat mixed astigmatism of up to 6.00 diopters.

A company statement says the FDA has granted four approvals in the past year, enabling an expanded range of vision correction treatments for the excimer laser, including up to -7.00 diopters of nearsightedness.

THOROFARE, N.J., April 2007 — People who develop unusual vision symptoms following LASIK are more likely to be diagnosed with higher-order aberrations after a procedure, according to study results published in the March issue of Journal of Refractive Surgery.

Investigators from different study sites say blurred vision was the most common type of unexpected vision symptom associated with LASIK. Other unusual symptoms included double vision (diplopia), halos, and vision fluctuation.

People experiencing these types of symptoms following LASIK also were diagnosed with significantly lower visual acuity and contrast sensitivity.

SALT LAKE CITY, March 2007 — Inflammation of the eye's surface (cornea) develops in almost 3 percent of people who undergo LASIK, according to a major study published in the March 2007 issue of the Journal of Cataract and Refractive Surgery.

Researchers at the John A. Moran Eye Center, University of Utah, studied outcomes from 1996-2004 of more than 10,000 LASIK procedures. Variables such as sterilization methods and larger volumes of procedures appeared to contribute to higher rates of eye inflammation known as noninfectious keratitis.

Keratitis generally can be managed through methods such as use of steroid eye drops, and/or lifting the flap created in LASIK to rinse off possible accumulations of cellular debris.

[Read more about LASIK complications.]

MADRID, Spain, February 2007 — Night vision problems such as seeing halos around lights following LASIK eye surgery may be related more to the amount of vision correction needed rather than to pupil size, according to researchers from Spain and Portugal.

Researchers said aberrations affecting night vision appear more likely when higher corrections are attempted, even when the LASIK outcome generally is considered successful. Researchers said large pupil size previously had been considered the more significant factor associated with night vision problems.

Study results were reported in the February 2007 online edition of British Journal of Ophthalmology.
 

DUBLIN, Calif., January 2007 — Carl Zeiss Meditec Inc. officials say an integrated vision correction surgery system using lasers both to create a thin flap on the eye's surface and to reshape the eye during LASIK will result from a recent U.S. Food and Drug Administration approval.

The FDA in early 2007 gave clearance for the company to market its laser flap-making technology, known as Visumax, along with the Mel 80 excimer laser for vision correction surgery. The company's excimer laser received FDA approval in late 2006.

A company news release says introduction of the integrated system to U.S. markets is planned for mid 2007. The laser eye surgery platform is designed so that eye surgeons can perform LASIK or other vision correction surgery with or without use of the Visumax femtosecond laser for creating flaps.

[Read a debate about blade vs. bladeless LASIK]

ROCHESTER, N.Y., January 2007 — Earlier scientific studies have investigated biocompatible materials known as corneal inlays that surgically can be inserted into the eye's clear front surface (cornea) potentially to correct presbyopia, which creates near vision problems in older adults.

Now, Bausch & Lomb has announced it has invested in corneal inlays for presbyopia correction with an exclusive option to buy the company developing the technology, AcuFocus Inc. based in Irvine, Calif.

Inside and outside the United States, AcuFocus has been enrolling presbyopic patients in human clinical trials aimed at testing the effectiveness and safety of the corneal inlay, known as the ACI 7000. A Bausch & Lomb news release says the corneal inlay is inserted beneath a thin flap of the type created during LASIK eye surgery. No sutures are used.

The inlay improves the presbyopic individual's ability to see a greater depth of field by blocking light rays from near objects that ordinarily would not be correctly focused by the eye, according to the AcuFocus web site.

"Current surgical presbyopic solutions involve compromises that can negatively affect the quality of vision for many patients," U.S. principal clinical trial investigator Daniel S. Durrie, MD, said in a news release. "The ACI 7000 corneal inlay is designed to remove those compromises through a safe and simple procedure. Moreover, pre-clinical studies performed outside of the United States show excellent early results and high patient satisfaction."

OTTAWA, Canada, January 2007 — Genetically engineered (recombinant) human collagen or an equivalent synthetic could be used to re-shape the eye's clear front surface (cornea) possibly as a new means of vision correction, according to researchers involved in early studies.

The method, known as corneal onlays, has been described in recent months in various ophthalmology trade journals, including the November 2006 issue of EuroTimes, published by the European Society of Cataract and Refractive Surgery.

Corneal onlays provide vision correction similar to implantable lenses, contact lenses, or intraocular lenses used in cataract surgery. But a corneal onlay, unlike artificial lenses, is a collagen or collagen-like substance made up mostly of liquid. The onlay more closely resembles the cornea itself.

One pioneer of the corneal onlay method is University of Ottawa professor and chairman of ophthalmology, W. Bruce Jackson, MD

The corneal onlay method could represent a future, non-invasive method of vision correction. The onlay is made up of artificially produced tissue similar to the eye's surface or cornea and can be used to reshape the eye. (Illustration provided by W. Bruce Jackson, MD)

"The corneal onlay method is non-invasive, no tissue is removed, and it is reversible," Jackson told AllAboutVision.com in December. "It can potentially treat a wide range of refractive errors and should restore vision quickly without the discomfort of surface procedures. New technology and materials make this a better option today than it was in the past."

In the procedure, the thin covering (epithelium) of the cornea is removed, and the corneal onlay rests in an artificially created "pocket" until the epithelium has a chance to heal.

"The main concern is keeping the onlay in place while the epithelium heals over the onlay, ensuring the power of the onlay remains stable over time and that the onlay achieves good centration," Jackson said.

Jackson said the method is being used in early stages of human testing and that it's difficult to predict if or when full clinical trials will begin.

"The concept is great, and very attractive to many refractive surgeons as a potentially excellent alternative to LASIK or PRK," Jackson said.

CHICAGO, January 2007 — Researchers say no clinically significant differences were found in one large study comparing outcomes of LASIK and LASEK vision correction surgeries.

A retrospective study of 2,257 eye surgeries conducted at the University of Illinois (UIC) at Chicago involved selecting and matching up patients with similar conditions, so that accurate comparisons could be made regarding outcomes of those who received LASIK or LASEK.

In LASIK, a laser or cutting instrument (microkeratome) is used to create a thin flap that is lifted before laser energy is applied to reshape the eye. The flap then is replaced to serve as a type of bandage to promote healing. In LASEK, a different, finer instrument is used to create and lift an ultra thin flap from the outermost covering of the eye (epithelium) before laser energy is applied to reshape the eye.

"Both procedures seem safe, effective, and predictable for the treatment of low to moderate myopia (nearsightedness)," UIC researcher Dimitri Azar, MD, said in a news release.

JENA, Germany/DUBLIN, Calif., December 2006 — Carl Zeiss Meditec officials say an advanced laser system (femtosecond) that creates LASIK flaps on the eye's surface during vision correction may be integrated into the company's new MEL 80 excimer laser system, approved by the U.S. Food and Drug Administration in August 2006.

"In addition to the advanced excimer laser platform offered by our MEL 80, we have also pursued the development of an advanced femtosecond laser system for flap creation," company president and CEO Jim Taylor said in a news release. "The ongoing clinical testing of these femtosecond technologies has been both more rapid and more promising than we had anticipated..."

Taylor said notification has been filed with the FDA regarding intent to market the laser device as an integrated part of the excimer laser system, which as of late 2006 had not yet been introduced in the United States.

Carl Zeiss Meditec officials say the company's new excimer laser used to ablate (remove tissue from) the eye's surface in LASIK is extremely fast, requiring patients to fixate on a light for only a few seconds before the procedure is completed. The company release also says the laser system preserves the cornea's shape, which reduces the possibility of vision errors (aberrations) related to complications following LASIK.

Clinical studies of the excimer laser leading up to FDA approval produced results showing that 93 percent of enrollees achieved 20/20 or better vision at three months, and 41 percent achieved 20/12.5 or better vision at six months. The FDA approval says the Carl Zeiss Meditec MEL 80 excimer laser can be used to treat nearsightedness up to -7.0 diopters, with or without astigmatism of up to -3.0 diopters.

[Ed note: In early November, IntraLase (Irvine, Calif.) in a lawsuit accused Carl Zeiss Meditec officials of improperly using proprietary information related to the IntraLase femtosecond laser that now is in widespread use for creating flaps in LASIK procedures. Carl Zeiss Meditec officials responded in a subsequent news release that the lawsuit claims have no merit.]

PORTLAND, Ore., October 2006 — After comparing data from several recent studies, an Oregon ophthalmology professor has concluded that laser eye surgery may be safer than wearing contact lenses long-term.

The chance of vision loss appears more likely with long-term contact lens wear than with laser eye surgery, said William Mathers, MD, of Oregon Health & Science University Casey Eye Institute in Portland, Ore.

"Several times a year, I have patients who lose eyes from complications because they've been wearing contacts and they've gotten an infection. By this, I mean their eyes have to be physically removed from their bodies," Mathers said in a news release.

"It's not that contacts aren't good. They're better than they've ever been. But one cannot assume contacts are safer."

In contrast, Mathers said the safety record of 18,000 laser eye surgery procedures conducted at Portland's Casey Vision Correction Center demonstrates that no patient has ever lost vision equivalent to two lines on an eye chart. Mathers also cited results from more than 32,000 U.S. military personnel undergoing laser eye surgery in which one in 1,250 lost one line of vision. There were no reports of loss of two lines or more of vision.

Mathers said that between 20 million and 25 million U.S. citizens wear contact lenses. About one million people in the United States undergo laser eye surgery annually.

[Read more about LASIK risks and caring for soft contact lenses.]

LONDON, September 2006 — A new and complex computer formula devised for the latest generation of excimer lasers used in LASIK vision correction reduces by nearly two-thirds the likelihood that repeat visits for enhancements will be needed, according to researchers at the University of Rochester Medical Center in New York.

With the new formula, researchers say LASIK eye surgeons are much more likely to receive the exact right vision correction in the first procedure.

Positive LASIK outcomes using the new formula were presented in September 2006 at the European Society of Cataract and Refractive Surgery meeting in London. Rochester researchers noted at the meeting that, while many LASIK patients do achieve 20/20 or better vision, they still might be slightly farsighted or nearsighted.

Researchers say the new computer formula for LASIK corrections accounts for the presence of many obscure vision errors known as higher-order aberrations that can affect vision outcomes. With the new computer formula, more people undergoing LASIK may now be able to achieve better than 20/20 vision.

STERLING, Va., August 2006 — WaveLight's excimer lasers used in LASIK and similar vision correction procedures now will be sold as wavefront-guided or wavefront-optimized depending on eye surgeon preference, based on a new U.S. Food and Drug Administration approval granted in late August 2006.

WaveLight's Allegretto Wave wavefront-optimized excimer laser has for several years used wavefront technology to help provide measurements for individual, customized treatment of the eye. With the newest FDA indication, the excimer laser now can also be wavefront-guided, which means that wavefront measurements automatically are built into the procedure as it takes place in real time.

A WaveLight news release says outcomes for either wavefront-guided or wavefront-optimized systems are similar, except when patients have a higher degree of complex vision problems known as higher-order aberrations. In those cases, results with a wavefront-guided system are slightly better. Company officials say neither type of WaveLight laser system induced symptomatic higher-order aberrations during clinical trials involving 374 eyes.

In clinical trials involving both WaveLight laser systems, all patients were able to see well enough to drive without vision correction such as spectacles at three months following LASIK.

The Allegretto Wave wavefront-guided system has FDA approval for treating up to -7 diopters of myopia with astigmatism of up to 3 diopters.

ST. LOUIS, August 2006 — Despite newer excimer lasers that can treat larger zones in the eye for vision correction, LASIK surgeons still are being advised to notify patients that larger pupil size may be associated with adverse LASIK outcomes.

Large pupil size was a major factor in a St. Louis jury's April 2006 decision to award $3 million in damages to a patient who sued a LASIK surgeon because of vision problems following a procedure. Some recent studies indicate that newer excimer lasers can create favorable outcomes in patients with larger pupils. But LASIK surgeons still should warn patients that large pupils can increase risks, according to discussion in the July 2006 issue of Review of Ophthalmology.

The article notes several reasons why large pupil size can adversely affect outcomes, including the increased possibility that aberrations may result when a larger zone is treated on the eye's surface to accommodate a larger pupil.

[Read more about LASIK risks and complications.]

STERLING, Va., July 2006 — The Allegretto Wave Eye-Q excimer laser system received FDA approval to correct up to -12D of myopia with up to -6D of astigmatism and up to +6D of hyperopia with up to 5D of astigmatism. The approved treatment range is the same as that of the 200 hertz Allegretto Wave system, and both systems are wavefront-optimized. But the new 400 hertz Eye-Q system provides a faster treatment time (one diopter of correction in two seconds with a 6.5 mm optical zone). WaveLight says this means patients, especially those with high myopia or high astigmatism, may now experience a shorter, more comfortable procedure than before.

SEOUL, Korea, July 2006 — Sensitivity of the eye's surface (cornea) appeared better preserved after LASEK eye surgery when compared with a LASIK procedure, Seoul, Korea researchers from various institutions concluded in study results reported in the June 2006 issue of the American Journal of Ophthalmology.

Researchers evaluated potential degeneration of nerve fibers on the eye's surface in 56 eyes of LASIK patients and 52 eyes of LASEK patients at three months and at six months following surgery. Researchers also noted that nerve fiber regeneration and recovery of corneal sensation with LASEK was similar to PRK eye surgery.

In LASIK, a thin, hinged flap is cut into the eye's surface. The flap then is lifted and laser energy is applied to reshape the eye. The flap is replaced to promote healing. LASEK is identical to LASIK, except that a much thinner hinged flap is cut into the eye's surface (epithelium) and floated out of the way with an alcohol solution. In PRK, no flap is cut into the eye's surface.

[Read more about LASEK, LASIK, and PRK.]

FORT WORTH, May 2006 — Eye surgeons should be able to complete LASIK and other vision correction procedures faster with the newest version of Alcon Inc.'s excimer laser, known as the LADAR6000.

Alcon company officials in Fort Worth announced in early May that the U.S. Food and Drug Administration had approved the new LADAR6000 platform, which has enhancements such as the ability to remove eye tissue 50 percent faster than previous LADARVision excimer laser platforms sold by the company.

Alcon officials said that the FDA also granted approval for expanded hyperopia and hyperopic astigmatism treatments for the industry's widest approved range from +0.75 to +5.00 diopters, with -3.00 diopters cylinder (focusing problems caused by astigmatism).

STERLING, Va., May 2006 — A new U.S. Food and Drug Administration approval means that people with focusing problems at both near and distant ranges, caused by a condition known as mixed astigmatism, now can undergo just one excimer laser vision correction with the WaveLight (Sterling, Va.) wavefront-optimized Allegretto Wave system.

Treating mixed astigmatism can be challenging because laser treatments typically used for nearsightedness (myopia) and farsightedness (hyperopia) must be applied to the eye's surface or cornea to achieve correction — often, in two consecutive treatments that involve removing corneal tissue each time, said FDA study investigator Michael Gordon, MD

"The new approval for the Allegretto Wave will enable ophthalmologists to provide one treatment while conserving more corneal tissue in comparison to other available approaches," Gordon said.

In announcing the new FDA indication in early May, WaveLight officials said the mixed astigmatism treatment is approved for naturally occurring astigmatism of up to 6 diopters.

The FDA study leading to approval involved 162 eyes treated at investigational sites throughout the United States At three months follow-up for 142 of the eyes, 68 percent achieved 20/20 vision and 95.8 percent achieved 20/40 vision postoperatively.

NEW YORK, April 2006 — Don't be fooled by a spoof web site known as LASIK@Home, which describes rather convincingly an entire home kit for performing your own LASIK eye surgery.

The web site purports to sell a $99.95 LASIK@Home laser kit that looks amazingly like a converted vacuum cleaner handle with assorted accessories including a sleep mask. You can't really order the kit, because the on-line form takes you to a blank page. But you can buy mugs, T-shirts, and other items inscribed with LASIK@Home.

In answer to e-mail questions, the New York individual who set up the web site said his or her identity will not be revealed at this time. The individual said many people who have written in — including from the press — have taken the site seriously.

While some money is being made from sales of spoof items such as inscribed cups and hats (not the purported LASIK kit) and Google ads, the individual indicated the main motive was just to have some fun.

"I've never had LASIK," the individual said in an e-mail response. "I'm a bit nearsighted, but I correct for that the old-fashioned way — by squinting. I know some people who have had successful LASIK surgery, and they seem very happy with the whole thing."

You might have a good laugh when you visit the LASIK@Home web site, but don't take it seriously. You can undergo LASIK eye surgery only in the hands of a qualified surgeon in a proper clinical setting. But you knew that. Right?

IRVINE, Calif., March 2006 — IntraLase Corp. has announced plans to introduce a newer, faster version of the company's laser used to create a hinged flap in the eye's surface during LASIK eye surgery.

The new 60 kHz laser was scheduled to be unveiled at the March 2006 meeting of the American Society of Cataract and Refractive Surgery (ASCRS) in San Francisco. An IntraLase company news release says the new platform will reduce the time needed to create a laser flap by half, to about 18 seconds.

In LASIK, a hinged flap in the eye's surface is created by either a bladed instrument (microkeratome) or a laser. The flap then is lifted, and energy from a different (excimer) laser is applied to reshape the eye for vision correction. The flap is replaced on the eye to promote faster healing and comfort.

COLUMBIA, Mo., February 2006 — Researchers say a common acne medication known as Accutane (isotretinoin, Roche) can cause dry eye and should not be given to patients who have had LASIK or who plan to undergo the procedure.

A University of Columbia, Missouri study revealed that all 50 ophthalmologists contacted appropriately screened potential LASIK patients to determine if they had used the acne medication. But none of 50 dermatologists surveyed asked acne patients about previous LASIK procedures before prescribing the medication.

Researchers said acne patients should stop using Accutane at least six months before undergoing LASIK and for six months after the procedure, to give the eye's clear front surface (cornea) time to heal.

Study commentary published in the January 2006 issue of the Journal of the American Academy of Dermatology noted that LASIK patients using Accutane within six months before or after a procedure could be at risk of dry eye and accompanying harmful effects on healing processes involving the eye's surface.

MONROVIA, Calif., January 2006 — An implantable contact lens that can be folded and inserted through smaller surgical incisions received U.S. Food and Drug Administration approval in late December 2005.

The Staar Surgical lens, known as the Implantable Collamer Lens (ICL), is being marketed in the United States as the Visian ICL. The FDA allows use of the lens for correcting nearsightedness or myopia, which causes blurry distance vision.

"We believe the ICL offers patients and their doctors opportunities to achieve higher quality visual outcomes compared with competing technology... This characteristic will be an important growth driver of the refractive phakic implant market," said Staar Surgical CEO and President David Bailey in a company news release.

The Staar Surgical ICL is the second implantable contact lens to receive FDA approval in the United States. The FDA approved the Verisyse (Ophtec USA and Advanced Medical Optics) in September 2004.

SANTA CLARA, Calif., September 2005 — The STAR S4 IR excimer laser system used with the CustomVue procedure received FDA approval to treat high myopia and myopic astigmatism of -6.00 to -11.00 diopters with up to -3.00 diopters of cylinder.

According to manufacturer Advanced Medical Optics (AMO), this means the CustomVue procedure now has the highest range of myopia and astigmatism treatment as well as approval for treatment of hyperopia and mixed astigmatism available on the U.S. market.

In clinical studies 98.3 percent of those receiving the CustomVue high myopia treatment were seeing 20/40 or better at six months after the procedure, with 84.3 percent seeing 20/20 or better. In May AMO acquired VISX, Incorporated, the manufacturer of the STAR excimer laser series and the CustomVue procedure, which uses wavefront technology to deliver custom LASIK that is personalized for each patient.

SANTA CLARA, Calif., March 2005 — More types of astigmatism can now be addressed with LASIK surgery using the VISX CustomVue system under a new U.S. Food and Drug Administration approval granted in March 2005, VISX company officials said.

VISX CustomVue uses wavefront-guided technology providing an individual "map" of how an individual's eye processes images. The new FDA approval expands allowable treatments with the CustomVue system to include astigmatism that occurs with farsightedness or nearsightedness, or astigmatism that causes vision defects at both near and far distances (mixed astigmatism).

"VISX is now the only U.S. provider of a wavefront-driven treatment for all forms of astigmatism," said VISX chairman and CEO Liz Davila in a news release.

Douglas Koch, MD, of Baylor College of Medicine's Baylor Vision, said that outcomes for astigmatism correction with CustomVue may be superior to correction provided by eyeglasses or contact lenses.

SANTA CLARA, Calif., March 2005 — Eye surgeons no longer will need to place marks on a patient's eye to aid alignment during laser vision correction because of a new, automated system that was just approved by the FDA.

FDA approval means VISX Inc. now can market and sell its Iris Registration system as the only automated technology of its type able to consistently target a specific area of the eye. During laser vision correction, Iris Registration maintains alignment even when the eye is rotating, according to the company.

"Iris Registration adds another level of sophistication to wavefront-guided laser vision correction," said Julian Stevens, MD, of Moorfields Eye Hospital, London, in a VISX news release. "By automatically adjusting the treatment for the eye's rotation, Iris Registration provides more individualized adjustments that improve the precision of laser vision correction. This further enhances the quality of vision we achieve with the procedure."

The company plans to begin shipments of the Iris Registration system including field upgrades for VISX WaveScan and VISX STAR excimer laser systems during the second quarter of 2005.

HOUSTON, March 2005 - On Friday, March 4, Anchorwoman Linda Lorelle of Houston's KPRC-TV underwent LASIK live on the Internet. Dr. Charles Moore of International EyeCare Laser Center performed the procedure with the Allegretto Wave excimer laser, which is manufactured by WaveLight. If you would like to view the archived webcast, please click here.

The webcast, which includes a question-and-answer session for viewers, can be viewed with the free Windows Media Player, which you may already have on your computer or which you can install before viewing.

SANTA CLARA, Calif., December 2004 — Because of a new U.S. Food and Drug Administration approval announced in December 2004, people who have near vision problems (farsightedness or hyperopia) may now undergo custom LASIK.

The CustomVue wavefront-guided excimer laser (VISX, Santa Clara, Calif.) as of late 2004 was the only custom LASIK system to have received FDA approval for treatment of hyperopia. The laser system reshapes the clear front portion of the eye (the cornea) using innovative technology that maps defects in the way each individual eye processes images.

"With this approval, VISX now offers our U.S. doctors the broadest range of wavefront-guided treatments," said VISX chairman and CEO Liz Davila. "We believe this further advancement of laser vision correction technology will enhance our market leadership position, drive CustomVue conversions, and increase future revenue and profit opportunities."

The FDA-approved excimer laser uses the VISX WaveScan System, representing wavefront technology that captures what company officials say is a type of fingerprint of each eye to allow individualized treatment for vision defects.

The company also says that clinical study results exceeded FDA requirements for safety and effectiveness. Study results indicate that four times as many people reported higher satisfaction with night vision following the custom procedure, than with contact lenses or eyeglasses.

December 2004 — Survey results from a questionnaire answered by 604 LASIK patients indicate that most people who have vision complaints following surgery would still be likely to recommend the procedure to friends. This means that using the assessment of whether a patient would recommend the procedure to others may not be an accurate measurement of the ultimate quality of the surgical outcome, according to findings reported in the September 2004 edition of the Journal of Cataract and Refractive Surgery.

Of the patients who answered the survey, 586 said they would recommend LASIK to friends, but only 434 replied to the "why or why not" question. Investigators studying results noted that a higher percentage of LASIK patients who had lingering complaints such as difficulty seeing at night declined to answer the "why or why not" question at a rate of 15 percent, compared with 4 percent of complaint-free patients.

Investigators noted that, even if patients had problems such as dry eye, perceived benefits may outweigh complaints. The December 2004 issue of Review of Optometry reported that survey participants with complaints may have responded that they had high levels of satisfaction as a way of resolving internal conflict about expected versus actual LASIK outcomes.

Patients who answered the survey question about why they would recommend LASIK listed "no more spectacles/contact lenses" as their top choice, followed by "better vision," "convenience," and "freedom."

FAIRFAX, Va., November 2004 — GP contact lenses (also called RGP contacts) shouldn't be worn in the three to six weeks before pre-LASIK eye examinations, says a study by researchers at the Massachusetts Eye and Ear Infirmary in Boston. Previously, it was thought that discontinuing wear for three weeks was sufficient.

Because GP contact lenses are somewhat rigid, they can change the shape of the cornea over time. But surgeons prefer to perform LASIK and other refractive procedures on a cornea that has returned to its natural shape after prolonged GP contact lens wear. This helps the surgeon to plan a more predictable result.

In the study of 55 eyes, 31 eyes achieved stability after three weeks of no lens wear. But it wasn't until the second exam, after six weeks of no lens wear, that the other 24 eyes were noted to have achieved stability. The study did note that the number of years that the GP lenses have been worn may increase the time to reach stability after no lens wear. It also noted that while GP lenses produce more effect on corneal shape, soft contact lenses can also change the shape somewhat. The study was written by Patricia Tsai, MD, in the Journal of Cataract and Refractive Surgery.

IRVINE, Calif., November 2004 — IntraLase Corporation has released preliminary clinical guidelines for using its laser for treatment of diseased corneas. The IntraLase laser is an alternative to the microkeratome used for making the flap in LASIK: instead of a blade, it uses laser energy. (Read more about IntraLase as used in LASIK.)

Now it can be used instead of a scalpel in anterior lamellar keratoplasty, which is the replacement of scarred or diseased corneal tissue with healthy donor corneal tissue. Computer software aids the laser in matching the shape of the removed and donated tissue pieces.

Another new use for the IntraLase is for creating the pocket into which intrastromal ring segments can be inserted to flatten the cornea in keratoconus patients. (Read more about keratoconus.)

SANTA ANA, Calif., September 2004 — People with high amounts of myopia (nearsightedness) may be interested in an alternative to LASIK that has just been approved by the FDA. The Verisyse phakic intraocular lens (IOL), made by Ophtec, has been available in other countries for many years under the name Artisan, but now it is available in the United States for adults age 21 or more with moderate to severe nearsightedness (-5.0 to -20.0 diopters).

The Verisyse phakic lens is designed for people who, in their surgeon's opinion, may not be good candidates for LASIK. Phakic IOLs are implanted in the eye's anterior chamber, in front of the natural lens that exists in a normal eye. This is unlike aphakic IOLs, which are implanted in place of the eye's natural lens, which has been removed, often because it has become cataractous.

The Verisyse lens is attached to the iris and can be surgically removed later if desired.

Pre-FDA approval studies showed 92 percent of 662 patients seeing 20/40 or better, with 44 percent seeing 20/20 or better. According to the FDA, one risk is a loss over time of endothelial cells below the cornea, so the agency requires that the lens be used only for people who have sufficient endothelial cell density to withstand such loss. Retinal detachment, corneal swelling, and cataracts were noted in a small percentage of the patients, and the FDA is requiring that Ophtec conduct a five-year study of these risks.

Advanced Medical Optics holds global distribution rights to the Artisan lens and is the exclusive distributor in North America and Japan.

FAIRFAX, Va., August 2004 — "We're finding that wavefront-guided LASIK yields sharper, higher quality vision, along with better patient satisfaction compared with conventional LASIK," said Captain Steven Schallhorn, MD, director of Cornea and Refractive Surgery at the U.S. Navy Medical Center in San Diego, in reference to a recent study he conducted on custom LASIK.

The study compared results for conventional LASIK patients with those for custom LASIK patients at the U.S. Navy's refractive surgery center. Three months after surgery, 94 percent of 78 patients who underwent wavefront-guided LASIK had 20/20 or better vision, while 86 percent of 178 patients with conventional LASIK saw 20/20 or better.

Also, 30 percent of conventional LASIK patients reported an increase in night driving halos with a satisfactory resolution after three months. But none of the custom LASIK patients reported night driving halos or glare. "While conventional LASIK is good, we're finding that wavefront-guided LASIK is giving us better results — better overall quality of vision and higher patient satisfaction," commented Dr. Schallhorn.

WINSTON-SALEM, N.C., May 2004 — Upon analyzing data from 368 LASIK procedures performed in North Carolina, researchers found a correlation between hot, humid weather and the need for follow-up LASIK. An average of 15.5 percent of the cases needed a second procedure; in the month of September, when outside humidity was high, the figure was 50 percent, but it was 0 percent during the drier months of winter.

Lead researcher Dr. Keith Walter, assistant professor of ophthalmology at Wake Forest University, said that higher humidity causes a small amount of swelling in the cornea due to hydration, which can lead to undercorrection during LASIK. He added that the study results didn't mean that people should avoid LASIK in the summer but that LASIK surgeons need to take temperature and humidity into account when planning their procedures and adjust their equipment and methods accordingly.

Laser manufacturers do make specific recommendations to laser centers to regulate their room temperature and humidity levels to ensure consistent patient results.

Dr. Walter's study was published in the Journal of Cataract and Refractive Surgery.

IRVINE, Calif., March 2004 — The FDA has cleared the ViewPoint CK System for performing conductive keratoplasty, also called NearVision CK, to correct presbyopia. The system, developed by ophthalmic device manufacturer Refractec, Inc., improves near vision with a tiny probe that applies radio waves in a ring-like pattern to gently heat collagen in the periphery of the cornea. The collagen shrinks, forming a kind of tightened belt around the cornea that steepens it to improve vision close-up.

The three-minute procedure results in better vision for reading and other near-point tasks, eliminating the need for reading glasses, progressive lenses, or multifocal contact lenses. Please read more about CK and other presbyopia correction methods.

JACKSON, Mich., March 2004 — A late-2003 survey related to an FDA clinical trial including 267 LASIK patients taken from 1995 to 1999 shows positive attitudes toward the LASIK procedure and a reduction in side effects over time.

Directly after their surgery, 73 percent of the patients reported seeing the same or less glare as before the procedure. But in 2003 63 percent said they saw no glare, with most saying the glare had occurred immediately after surgery but had diminished over time.

After surgery, 52 percent said they saw the same or less halo, but in 2003 62 percent showed no halos. After surgery, 79 percent said they saw the same or less ghost images, but in 2003 89 percent saw no ghost images.

Ninety percent said they were free from full-time use of eyeglasses or contact lenses, and 91 percent said LASIK had improved their quality of life and they would recommend it to others.

Faculty members at Emory University Medical School conducted the survey.