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Investigator Reports 99.4% Patient Satisfaction Rate as Part of First Three Year Follow Up Results on STAAR Surgical's Implantable Contact Lens (ICL) for Myopia

  • 2003-04-14
  • Press release
 Dr. Stephen Slade Reports Complication Levels of One Percent as Part Of
                          Three Year Follow Up Study

SAN FRANCISCO, April 14 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA) today reported that Stephen G. Slade, M.D., an investigator of STAAR Surgical's Implantable Contact Lens (ICL), has presented the first three year follow up interim results of the ICL at the American Society of Cataract & Refractive Surgery symposium being held here. The results represented 36-month follow up after the ICL was implanted into 369 eyes.

According to Dr. Slade, the results were exceptional. The mean level of myopia for the 369 eyes was minus 10.12 diopters. Dr. Slade reported that 95% of the patients with good pre-operative visual acuity targeted for emmetropia (zero postoperative correction) had uncorrected visual acuities of 20/40 or better and that 57% had uncorrected visual acuities better than their best corrected visual acuity preoperatively. In addition, 38% gained one line on a standard eye chart of BSCVA (Best Corrected Visual Acuity) and 10.8% gained two or more lines on a standard eye chart of BSCVA.

Stability of the procedure was well demonstrated with less than 0.1 diopter change in result from one week postoperative to 36 months postoperative as well as predictability with 68% within 0.5 diopter of attempted correction, 88% within one diopter and 98% within two diopter. Complication rates were extremely low with three cataract extractions (0.6%) and two clinically significant anterior subcapsular opacities (0.4%). One of the most exciting findings, according to Dr. Slade, was that 99.4% of the patients were satisfied with their ICLs three years after implantation.

"The quality of vision and patient satisfaction levels we have seen in this study clearly position the ICL as a compelling choice for a wide range of myopes. In addition the low complication rate after three years of follow up in a controlled trial establishes a new standard for phakic implants," said Dr. Slade.

In addition to the three year data presentation, the ICL is receiving a high level of exposure at this year's ASCRS meeting as evidenced by 17 scientific presentations from around the world ranging from favorable comparisons to LASIK to ICL follow up with ten year post operative results. This increased activity is a direct result of the high patient satisfaction achieved with the lens as well as improved physician confidence in the product and procedure. An upcoming publication, approved for May 2003 issue of Cornea, The Journal of Cornea and External Disease, "Comparison of the Implantable Contact Lens with Laser Assisted In Situ Keratomileusis for Moderate to High Myopia" continues to support the desirable patient outcomes experienced with ICL.

"We are clearly very pleased with the three year outcomes reported by Dr. Slade. These unprecedented patient satisfaction levels underline our belief that the ICL represents the next paradigm shift in refractive surgery," said David Bailey, President & CEO of STAAR Surgical.

STAAR Surgical will host a presentation for the investment community today at the ASCRS symposium. David Bailey and John Bily, CFO, will review recent ICL developments and Dr. John Vukich, Dr. R. Gale Martin and Dr. Slade will provide an overview of their clinical experiences with the ICL during a roundtable discussion. Interested parties may access the presentation via a webcast beginning at 3 p.m. PT. The webcast is available at www.staar.com, select financials, select conference calls. The webcast will be archived at the same website address through the end of April.

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 Implantable Contact Lens as well as innovative products designed to improve patient outcomes for cataracts and glaucoma.

CONTACT: David Bailey, President & CEO, +1-626-303-7902, or Helene Lamielle, Vice President, +1-626-303-7902, both of STAAR Surgical Company; or investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn, +1-415-659-2289, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group, for STAAR Surgical Company

SOURCE  STAAR Surgical Company
    -0-                             04/14/2003
    /CONTACT:  David Bailey, President & CEO, +1-626-303-7902, or
Helene Lamielle, Vice President, +1-626-303-7902, both of STAAR Surgical
Company; or investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn,
+1-415-659-2289, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group,
for STAAR Surgical Company/
    /Web site:  http://www.staar.com/
    (STAA)

CO:  STAAR Surgical Company
ST:  California
IN:  HEA MTC
SU:  SVY CCA



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0651 04/14/2003 10:35 EDT http://www.prnewswire.com