New Science of LASIK Reveals IntraLase Laser Key to Better Than 20/20 Vision; ASCRS Data Show LASIK’s First Step - Creation of the Corneal Flap - Underestimated for Its Affect on Visual Outcomes
American Society of Cataract and Refractive Surgery Meeting
WASHINGTON--April 15, 2005--
Corneal Architecture “Below-the-Flap” Found Integral to Better Vision
A previously overlooked aspect of the LASIK procedure, the creation of the corneal flap, plays a significant role in the visual outcome of the procedure, according to new clinical research being presented this week at the annual meeting of the American Society for Cataract and Refractive Surgery (ASCRS) in Washington, D.C.
Data from multiple clinical studies show statistically and clinically significant differences in the vision patients achieve when the IntraLase(R) FS laser (IntraLase Corp. (NASDAQ:ILSE)) is used for corneal flap creation in LASIK’s first step. It appears the IntraLase laser, originally designed to create a safer flap, also provides for vision better than 20/20, particularly among Custom LASIK patients.
“Until now, the role of the corneal flap has been underestimated,” said Roger F. Steinert, M.D., 2005 ASCRS President, Professor of Ophthalmology, Professor of Biomedical Engineering, Director of Cornea, Refractive and Cataract Surgery, and Vice Chair of Clinical Ophthalmology at University of California, Irvine. “When we began using the IntraLase laser to make corneal flaps, more patients achieved vision better than 20/20, to 20/15 and even 20/12.5. We found IntraLase-initiated LASIK does more than create a safer, more precise flap. These outcomes relate directly to what the IntraLase laser does below the flap: creating an optimal corneal architecture for the procedure’s second step, treatment by the excimer laser. If the corneal surface is left with microscopic high and low spots, or irregular hydration, the precision of the excimer tissue ablation can be compromised, and with it the visual outcome.”
Highlights of the new findings, including those being presented at ASCRS, include:
-- A greater number of standard and Custom LASIK patients achieve visual results better than 20/20 to 20/15 and 20/12.5 with IntraLase-initiated LASIK. (Durrie, Faktorovich, Manche, Tanzer/Schallhorn)
-- Prospective, randomized evaluation of wavefront aberrations shows the IntraLase laser induces fewer higher- and lower-order aberrations (associated with night glare and halos), allowing for a corneal surface consistent with wavefront recordings taken pre-operatively. (Lim, Tran)
-- The planar architecture of the IntraLase flap and corneal bed significantly reduces the incidence of post-operative induced astigmatism - a complication that occurs with some frequency with the microkeratome. (Kezirian, Stonecipher)
-- Patients who stated a preference in prospective, randomized clinical trials chose the post-operative vision of their IntraLase-treated eye up to 3-to-1 over their blade-treated eye. (Durrie, Manche)
Dr. Steinert, who also co-authored the ASCRS Eye Surgery Education Council LASIK Guidelines, added: “As surgeons, we are driven to increase our scientific understanding to ensure the best possible visual outcomes are realized by our LASIK patients. The IntraLase laser is the latest example of the new science of LASIK.”
How the IntraLase Laser Works
Pulsing at a speed of one-quadrillionth of a second, the ultra-fast IntraLase FS30 femtosecond (fem-to-second) laser uses an infrared beam of light to prepare the intracorneal bed and create the flap, using an “inside-out” process to complete the first step of LASIK.
-- The beam of laser light is focused to a precise point within the cornea where a string of microscopic bubbles is formed.
-- Thousands of these tiny bubbles are precisely positioned to define the architecture of the intracorneal surface, as well as the distinct beveled edge of the resulting flap.
-- Bubbles are then stacked along the edge up to the corneal surface to complete step one.
-- The IntraLase process from start to finish takes under 30 seconds, on average.
-- The physician then lifts the flap to expose the prepared corneal bed for treatment by the excimer laser (the second step of LASIK).
-- The LASIK procedure is completed when the flap is securely repositioned thanks to its beveled edge.
The creation of a corneal flap prior to treatment by the excimer laser was added to laser vision correction in the mid 1990s to provide patient comfort and immediate visual results (the two factors credited with the growth and popularity of LASIK). When laser vision correction was performed without the corneal flap - as in PRK (photorefractive keratotomy) - patients experienced considerable discomfort, as well as a delay in visual acuity. So, in LASIK, the surgeon first creates a micro-thin corneal flap, which is then lifted to expose the inner cornea for the second step, vision treatment by an excimer laser.
Historically, the first step of LASIK was performed using a hand-held device with an oscillating metal razor blade, called a microkeratome. While LASIK has proven to be a successful and relatively safe procedure, it is the microkeratome that caused the majority of LASIK complications.
With the IntraLase laser, the surgeon can precisely control the critical first step of LASIK. Physician-programmed laser specifications include flap diameter, depth, hinge location and width, and side-cut architecture - factors which can be varied to meet the individual patient’s needs. The IntraLase laser also creates a distinctive beveled edge flap, which allows for precise repositioning, alignment and seating after LASIK is completed.
About IntraLase Corp.
IntraLase (NASDAQ:ILSE) designs, develops and manufactures an ultra-fast laser, related software and disposable devices used to create a corneal flap, the first step in LASIK surgery for the correction of vision. The company’s products improve the safety, precision and visual results of LASIK procedures by providing a computer-controlled laser solution in place of the hand-held mechanical, metal-bladed microkeratome traditionally used to create corneal flaps. IntraLase lasers are also used in surgical approaches to the treatment of diseased corneas. The company’s lasers and disposable per procedure patient interfaces are presently marketed throughout the United States and 17 other countries. IntraLase is has headquarters and manufactures its products in Irvine, Calif. For additional information, visit the company’s Web site: www.intralase.com.
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “project,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” or “may.” Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Those risks and uncertainties include, but are not limited to: the degree of continued acceptance of LASIK surgery; potential complications revealed by long term follow up; the extent of adoption of our product offering by LASIK surgeons; general economic conditions; changes in federal tax laws governing the ability of potential LASIK patients to use pre-tax dollars to pay for LASIK surgery; the scope of government regulation applicable to our products; patients’ willingness to pay for LASIK surgery; our ability to compete against our competitors; the effectiveness of our measures to ensure full payment of procedure fees; the occurrence and outcome of product liability suits against us; our ability to adequately protect our intellectual property; whether we become subject to claims of infringement or misappropriation of the intellectual property rights of others; the continued availability of supplies from single-source suppliers and manufacturers of our key laser components; the ability of our managers, operations and facilities to manage our growth; the success of our expansion into markets outside the United States; whether we lose any of our key executives or fail to attract qualified personnel; or if our new products or applications fail to become commercially viable.
Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company’s annual report on form 10-K for the period ending Dec. 31, 2004, as filed with the Securities and Exchange Commission on March 29, 2005.
These forward-looking statements are made only as of the date of this press release, and the company assumes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
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