Example research essay topic: Clinical Trials Baby Boomers - 1,366 words

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Kimberly Goolsby (949) 464 - 0187 FOR IMMEDIATE RELEASE FDA APPROVES REFRACTEC's (R) CKSM (Conductive Keratoplasty SM) NON-LASER PROCEDURE FOR FARSIGHTEDNESS CK Uses Radiofrequency Energy, Instead of a Laser, to Reshape the Cornea Without Cutting or Removing Tissue IRVINE, Calif. , April 16, 2002 - Ophthalmic device manufacturer Refractec Inc. today announced that the U. S. Food and Drug Administration has approved CK (Conductive Keratoplasty), a procedure for farsightedness (hyperopia) in people over age 40.

CK utilizes the controlled release of radiofrequency (RF) energy, instead of a laser or scalpel, to reshape the cornea. The minimally invasive CK procedure takes less than three minutes and is done in-office with only topical (eye drop) anesthesia. Farsightedness, which occurs when the cornea is too flat or the eye is too short, is the most common vision disorder in America and affects more than 60 million people over age 40. Symptoms include difficulty reading menus, a computer screen and seeing to drive at night, or the need to constantly reposition reading material to find the right focus. "For years, the farsighted have been left behind as vision correction progressed: RK (radial keratonomy), PRK (photo refractive keratectomy) even LASIK (Laser In-situ Keratomileusis) initially, were all treatments designed specifically for the nearsighted, " said world-renowned ophthalmologist Marguerite B.

McDonald, MD, medical monitor for the FDA clinical trials, director of the Southern Vision Institute and clinical professor of ophthalmology at Tulane University, New Orleans, La. "CK is one of the first procedures designed specifically for the millions of people with hyperopia. " (more) FDA Approves CK Page 2 of 4 Due to the flatness of the cornea, farsightedness is the most difficult disorder to treat with LASIK and the most likely to cause complications, according to Robert K. Maloney, MD, principal FDA clinical investigator and director of the Maloney-Seibel Vision Institute in Santa Monica, Calif. "Hyperopic LASIK accounts for about 20 percent of my practice, but 80 percent of the complications, because hyperopic patients are more likely, after LASIK, to get dry eyes, hazy vision or poor quality of vision, " said Dr. Maloney. Procedure Appeals to Risk-Adverse Baby Boomers Baby Boomers (those born between 1946 and 1964) comprise the largest segment of the farsighted population, and many view the need for glasses as a sign of aging. Yet, hyperopic procedures comprised only a small percentage of the nearly 2 million U. S.

refractive surgeries performed last year. Consumer research indicates that, to date, very few people between the ages of 40 to 60 have even considered vision correction surgery, as they tend to be more conservative and risk-adverse than their younger, nearsighted (myopic) counterparts. "CK meets the needs of the risk-adverse patient population, those who " ve been waiting for a safe, less-invasive treatment for farsightedness, " said Dr. Maloney. "As the first approved alternative to a laser for treating hyperopia, it's a very effective procedure and most of all, the patients love it. It's quick. There's very little post-op discomfort and immediate return of vision. ' About the CK Procedure CKSM can change how the eye focuses light by reshaping the cornea. CK uses a controlled release of radiofrequency energy to heat and shrink the corneal tissue, which steepens the cornea.

This steepening results in the desired refractive effect. (more) FDA Approves CK Page 3 of 4 "In the CK procedure we apply radiofrequency energy to the eye through a tiny probe as thin as a human hair, " said Dr. Maloney. "We apply this energy in a circle and it causes constriction, almost like tightening a belt, which increases the curvature of the eye to treat farsightedness. " The use of RF energy is one of today's most advanced surgical techniques. In addition to its use in CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular procedures. "During the CK Clinical Trials everybody we treated had an improvement in vision, " said Dr. McDonald. "And it's safe - incredibly safe. That's due to the fact that these radiofrequency waves do not remove any tissue from the eye, there's no cutting and that, we think, makes it a very attractive option for millions of patients. ' The Refractec Viewpoint TM CK System received premarket approval for the temporary reduction of spherical hyperopia in patients who have 0. 75 D to 3. 25 D of cyclopedia spherical hyperopia, with less than or equal to 0. 75 D of refractive astigmatism (minus cylinder format), and a cyclopedia spherical equivalent of 0. 75 D to 3. 00 D. Patients must be 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than 0. 50 D in spherical and cylindrical components of the manifest refraction.

The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction. (more) FDA Approves CK Page 4 of 4 The immediate market application for CK is substantial and growing according to Mitchell B. Campbell, president of Refractec. "As many as 40 million Americans are estimated to be over age 40 with low to moderate hyperopia (+ 0. 75 to + 3. 00 diopters), the approved indication for CK. And, when you consider that very few of the nearly 2 million refractive procedures are performed to help farsighted patients, you can see the huge potential for CK. These patients are looking for a procedure that they think is safe and easier to undergo and at present, CK is the only alternative to laser, " said Campbell. About Refractec Refractec Inc. is a privately held ophthalmic company that develops and markets new ways for ophthalmologists to effectively treat refractive errors with its proprietary Conductive Keratoplasty SM (CKSM) technology.

Refractec is "Reshaping Vision Correction TM" and changing patient outcomes. The company is headquartered at 5 Jenner, Suite 150, Irvine, Calif. Patients can visit (web) or call 1 - 800 - 752 - 9544 for more information on CK and to obtain a list of physicians nationwide offering the procedure. The Refractec Viewpoint TM CK System received premarket approval for the temporary reduction of spherical hyperopia in patients who have 0. 75 D to 3. 25 D of cyclopedia spherical hyperopia, with less than or equal to 0. 75 D of refractive astigmatism (minus cylinder format), and a cyclopedia spherical equivalent of 0. 75 D to 3. 00 D.

Patients must be 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than 0. 50 D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction. CKSM is an elective procedure with the alternatives including, but not limited to, eyeglasses, contact lenses, photo refractive keratotomy (PRK), laser in situ keratomileusis (LASIK), or laser thermal keratoplasty (LTK). The premarket approval of CK is based on a clinical trial of 401 eyes (233 primary and 168 secondary).

Of all eyes treated, 358 eyes were available for analysis at 3 months, 352 eyes were available for analysis at 6 months, 350 eyes were available for analysis at 9 months, and 344 eyes were available for analysis at 12 months. Accountability was 99 % at 3 months, 97 % at 6 months, 96 % at 9 months, and 99 % at 12 months. The data analysis was based on the refractive data at all follow-up examination time points (1 month, 3, 6, 9, and 12 months). At 12 months, this analysis showed that 318 / 344 (92 %) eyes were corrected to 20 / 40 or better and 191 / 344 (56 %) were corrected to 20 / 20 or better visual acuity without spectacles or contact lenses. The study showed that all adverse events occurred at low rates (< 1 %). Long-term risks of CK for hyperopia have not been determined.

The safety and effectiveness of re-treatment procedures with the Refractec Viewpoint TM CK System or other refractive surgical devices have not been established. FD 02 - 005 # # #

Research essay sample on Clinical Trials Baby Boomers