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Study Concludes STAAR's ICL(TM) Is Safer and More Effective Than LASIK

  • 2003-05-15
  • Press release

Results of Study Published in Cornea

MONROVIA, Calif., May 15 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA) a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported that the May 2003 edition of Cornea, The Journal of Cornea and External Disease has published the findings of a study comparing the results of laser assisted in situ keratomileusis (LASIK) and implantable contact lenses (ICL).

The article entitled "Comparison of Implantable Contact Lens and Laser Assisted In Situ Keratomileusis for Moderate to High Myopia" authored by Donald R. Sanders, M.D., Ph.D. and John A. Vukich, M.D., concludes that the ICL is safer, more effective and appears to be a viable alternative to LASIK, which utilizes corneal refractive excimer lasers, in the treatment of moderate to high myopia.

In the article, the postoperative results of 210 eyes implanted with the ICL are compared with the postoperative results of 559 eyes on which LASIK surgery was performed. All of the patients were examined at one day, one week, one month, six months and one year postoperatively. The average level of myopia for the ICL patients was minus 9.1 diopters and the LASIK surgery patients had a slightly lower level of myopia at an average of minus 9.8 diopters.

Drs. Sanders and Vukich reported that in every index of BSCVA (Best Spectacle Corrected Visual Acuity), UCVA (Uncorrected Visual Acuity), predictability of refraction and stability of refraction, the ICL outperformed the LASIK procedure. After six months, the study indicated that while seven percent of ICL patients had gained two or more lines on the standard eye chart of BSCVA, only three percent of LASIK surgery patients had gained two or more lines and two percent of LASIK patients had actually lost two or more lines on the chart.

After six months, the predictability of the ICL procedure was much higher with 90% of patients within 1 diopter of attempted correction and 65% within 0.5 diopters. LASIK surgery had statistically significantly less favorable results with only 76% of patients within 1 diopter of attempted correction and 53% within 0.5 diopters after six months. The ICL also scored higher in the UCVA 20/20 or better comparison with 50% of those treated achieving 20/20 vision or better, while 35% of LASIK patients reached this level of visual acuity.

"We are very pleased with the results of this study which are quite encouraging," said David Bailey, president and CEO of STAAR Surgical. "The favorable comparisons between our industry-leading phakic technology and LASIK technology further underscore the radical paradigm shift in refractive surgery that we believe the ICL represents. This study clearly illustrates that the ICL offers patients a more predictable alternative to LASIK."

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.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any projections of earnings, revenue, or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, 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 the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, general domestic and international economic conditions, and other factors beyond the control of STAAR Surgical Company, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation and does not intend to update these forward-looking statements.

CONTACT: investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn, +1-415-659-2289, or media, Sheryl Seapy, 415-272-3323, all of EVC Group, for STAAR Surgical Company

SOURCE  STAAR Surgical Company
    -0-                             05/15/2003
    /CONTACT:  investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn,
+1-415-659-2289, or media, Sheryl Seapy, 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:  MTC BIO HEA
SU:  SVY



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8299 05/15/2003 09:20 EDT http://www.prnewswire.com