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First STAAR Surgical Toric Implantable Contact Lens (TICL(TM)) Implanted in U.S. Clinical Trial

  • 2002-09-06
  • Press release
MONROVIA, Calif., Sep 6, 2002 /PRNewswire-FirstCall via COMTEX/ --

Twenty-four hour post check-up show outstanding results for only posterior phakic lens that reduces pre-existing astigmatisms while providing visual correction for nearsightedness

STAAR Surgical Company (Nasdaq: STAA) announced that John Vukich, M.D., of Davis Duehr Dean Medical Center in Madison, Wisconsin, implanted the first Toric Implantable Contact Lens (TICL(TM)) in the U.S. clinical study on Thursday, August 29th. The patient was severely nearsighted with significant astigmatism (-10.25 diopters +4.00 diopters), barely able to see his fingers to count them. At twenty- four hours post-operative, his vision improved to 20/30 -1 diopter, good enough to pass a driving test without glasses.

The procedure was done under a clinical investigation of the TICL in the United States with patients having myopia in the range of -3.0-to 20.0 diopters and astigmatism in the range of 1.0 to 4.0 diopters. The United States Food and Drug Administration issued conditional approval for an Investigational Device Exemption (IDE) for the ICL in January. The clinical study will include 125 patients with one-year follow-up.

The TICL is the only posterior phakic intraocular lens able to both reduce pre-existing astigmatism and provide patient with visual correction for myopia. According to industry sources, approximately 20 percent of the population suffer from astigmatism, a corneal irregularity causing impairment of sight, with the percentage much higher among severe myopic patients, the market the TICL serves.

The patient, Ron Nagel said, "I have worn glasses since the first grade. The best part of the procedure was waking up this morning and being able to see the clock for the first time in my life without my glasses."

John Vukich, M.D., who performed the surgery commented, "This is the next step in the evolution of the phakic Implantable contact lens (ICL). We are now able to offer correction through one lens for extremely wide range myopia and astigmatism to a group of patients who had little or no alternatives before this." He continued, "I believe that STAAR has reached a milestone with this lens and look forward to enrolling patients as quickly as possible."

"We have been expanding manufacturing in Switzerland to allow us to efficiently make the Toric ICL and have achieved much improvement in this area," stated David Bailey, President and CEO for STAAR. "This is another important milestone in our commitment to provide innovative breakthrough technology to the ophthalmic industry and it benefactors."

Bailey added, "We firmly believe the development of the phakic implant market will be accelerated with the introduction of the TICL. Doctors and patients want the convenience of being able to correct moderate to severe myopia and astigmatism in one procedure. This, combined with the excellent quality of post-operative vision, will help drive demand for the product. STAAR led the industry with the development of the ICL and we intend to build on this leadership position with the Toric ICL."

The company also reported that U.S. clinical trial on the Implantable Contact Lens (ICL) is showing excellent results. Helene Lamielle, Vice President of Scientific Affairs said of the trials, "We are very pleased with the clinical data on the ICL. Having received over a third of the clinical data on the three years post operative visits, there has been no surprises in the outcome, and we are very satisfied with the results."

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) which is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) Collagen Glaucoma Drainage Device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) available in Europe and all except the ICL(TM) in the United States.

For additional information, about STAAR Surgical, visit the Company's web site at or You may wish to contact David Bailey, President, STAAR Surgical, or John Bily, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Wayne Buckhout, CTC Inc., please call (937) 434-2700

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SOURCE STAAR Surgical Company

CONTACT:          David Bailey, President, or John Bily, Chief Financial Officer
                  of STAAR Surgical, +1-626-303-7902; or Bill Roberts, President, or Wayne
                  Buckhout of CTC Inc., +1-937-434-2700

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