To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Nation's First Implantable Contact Lens Procedure Completed URL: http://www.pslgroup.com/dg/1F7DA.htm Doctor's Guide March 5, 1997
SOUTHWEST Fla., March 5, 1997 -- David C. Brown, M.D., founder and medical director of Eye Centers of Florida, successfully completed the nation's first implantable contact lens procedure using The Staar Surgical Company (Nasdaq: STAA), implantable contact lens, at 4 p.m. today. Dr. Brown was chosen as one of just four ophthalmologists in the United States to participate in a multi-phase clinical study to investigate the implantable contact lens (ICL). The ICL is a revolutionary medical breakthrough for the permanent correction of nearsightedness or farsightedness. The FDA-approved study will monitor the safety and effectiveness of a surgically implanted contact lens in carefully selected subjects with a moderate to high degree of myopia (nearsightedness) or hyperopia (farsightedness). It is sponsored by STAAR Surgical Company, based in Monrovia, Calif., which introduced the highly successful foldable lens implant for cataract surgery in 1984; the STAAR Surgical intraocular lens is now used by progressive cataract surgeons nationwide. Dr. Brown is an internationally recognized specialist in cataract surgery who has participated in a number of national clinical studies for STAAR Surgical and other leading companies. He was one of the first surgeons to test the STAAR foldable lens and pioneered the "no-stitch" cataract surgery procedure in Florida in 1991. Traditionally, Dr. Brown said, refractive error has been treated with eyeglasses or regular contact lenses; however, the moderate to highly hyperopic or myopic patient may consider these methods unsatisfactory for functional, aesthetic or cosmetic reasons. Difficulties may include limitations on sporting activities, job related restrictions or problems with loss or breakage. The STAAR Surgical ICL, Dr. Brown said, represents a viable alternative to all of the current treatments of refractive error: "Unlike, for example, excimer laser surgery, in which the cornea is reshaped, the patient's eye is not surgically altered," he said. "The natural crystalline lens, removed during cataract surgery, remains in place. The ICL is placed between the natural crystalline lens and the iris." Using injection systems already widely used for placement of STAAR intraocular lenses during cataract surgery, the surgeon will place the ICL through a closed, sterile pathway through a clear corneal incision no larger than 3 mm. Post-surgical complication, such as infection or surgically induced astigmatism, is minimized. The implantable contact lens was developed by STAAR Surgical AG of Nidau, Switzerland, and is being tested for the first time in the United States, following more than two years of successful clinical use in Europe and the Caribbean. Dr. Brown participated in these international clinical studies which achieved excellent safety results. The STAAR Surgical study is designed to enroll 350-500 subjects nationwide in three phases beginning with just 10 subjects at four sites in Phase I. Eye Centers of Florida, with Dr. Brown as chief investigator and surgeon, has been selected as one of these four. Selection was based, study organizers said, on reputation, experience and measurable quality standards both for the participating surgeon and for the surgical facility. All participating surgeons, already experts in intraocular lens implantation, will receive advanced training in the ICL procedure. Study subjects will be healthy adults aged between 21 and 45 years with a moderate to high measured degree of farsightedness or nearsightedness, stable for at least 12 months and correctable with their current prescription to at least 20/100 in the treated eye. Subjects must also demonstrate both capability and willingness to follow the conditions of the study including attendance at follow-up examinations for at least two years. Exclusion criteria include previous history of ocular surgery including refractive surgery; diabetes, glaucoma or other vision-threatening disease; ocular hypertension or clinical signs of iritis or uveitis. FDA has given approval for initiation of the Phase I study. Following six months of careful observation and follow-up on these subjects, Phase II, with 50 to 125 new subjects, is expected to begin. Eye Centers of Florida, founded by Dr. David C. Brown in 1982, is a nationally recognized, progressive eye care center providing complete vision care to individuals throughout Southwest Florida. The practice currently has a staff of more than 250, including a medical staff of six Board-certified ophthalmologists, 23 Board-certified optometric physicians and a qualified team of specialist providers. In addition to surgery centers and offices in Fort Myers and Venice, Eye Centers has offices in Arcadia, Bonita Springs, Cape Coral, Clewiston, Englewood, Fort Myers Beach, Immokalee, Lehigh Acres, Port Charlotte, Naples, South Fort Myers and provides optometric services at Rubin Optical in Punta Gorda. As part of an ongoing community outreach effort, a fully equipped mobile unit regularly visits locations throughout the region providing free eye screening for prevention of blindness, hearing loss screening and eye health information. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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