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STAAR Surgical Company Presents New ICL Clinical Data

  • 2001-09-19
  • Press release

MONROVIA, Calif., Sept. 19 /PRNewswire/ -- STAAR Surgical Company ("STAAR") presented new clinical data from its FDA clinical trial for the ICL(TM) (Implantable Contact Lens) at the second in a series of surgeon training courses being held in Canada. The data shows a very low rate of lens opacities associated with the implantation of the ICL.

The U.S. FDA clinical trial is separated into two portions, the first for myopic (nearsighted) patients and the second for hyperopic (farsighted) patients. The newest clinical results for the myopia study showed 12 lens opacities (2.3%) in a study population of 529 cases. Of these, 8 (1.5%) were seen early in the postoperative period and were non-progressive with no loss of best-corrected visual acuity at the last visit. These were most likely due to mild trauma at the time of surgery. Results for the hyperopia study were very similar with 4 lens opacities reported among 178 eyes. Of the 4, one center was responsible for 3 opacities that resulted in 2 cataract extractions. In the remaining 174 eyes implanted by 23 investigators, only one (0.6%) lens opacity was observed with no loss of best-corrected visual acuity. No late anterior subcapsular lens opacities were seen and no cataract extractions have been required.

"The data is very gratifying," said David Bailey, STAAR's CEO and President. "The rate of lens opacities was higher with our initial lens designs and before we had refined the method for determining lens size. The U.S. study confirms that with appropriate lens design and accurate sizing, the ICL produces excellent visual outcomes."

Bailey said, "The clinical investigators in the U.S. trial followed STAAR's surgical protocol which is now being taught at the Canadian training courses." He then added, "There is a learning curve with every new procedure or device. These numbers are particularly impressive when you consider that many of these implantations were done by clinical investigators just developing their surgical techniques."

STAAR has established several STAAR ICL Centers of Excellence in Canada where surgeon training is being conducted. The first course was held on August 21st at the Gimbel Eye Center in Calgary, Alberta with Howard V. Gimbel, M.D. and John Vukich, M.D., the Medical Monitor for the U.S. FDA clinical trial, instructing. The second course was held on September 11th at TLC, Windsor, Ontario under the direction of Lou Probst, M.D. The next course will be held at the Montreal Eye Centre with Sameh Fanous, M.D. as course director. Attendees at the courses are provided information on patient selection, accurate sizing and calculation, intra-operative surgical technique, post-operative care and complication management. The courses focused on "best practice" application to ensure successful outcomes as demonstrated within the U.S. clinical trial. Additional courses are scheduled for October 15th, November 9th and November 29th. STAAR received a Medical Device License for its ICL from Health Canada in July, clearing the way to begin early distribution of the ICL throughout Canada.

The ICL is a surgically implanted lens that uses optical concepts similar to contact or spectacle lenses to achieve vision correction. As with spectacle lenses, each ICL is selected to address the individual patient's refractive error. Surgeons implant the ICL in front of the human lens in a matter of minutes. Unlike laser refractive correction, the ICL makes no permanent change in the structures of the eye and the procedure is reversible.

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) that 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 available in Europe and all except the ICL(TM) in the United States.

Certain statements in this press release constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on expectations as of the date of a particular release. Actual results may differ materially from those projected because of a number of risks and uncertainties, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission.

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

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SOURCE STAAR Surgical Company

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