IRVINE, Calif. -- Ophthalmic device manufacturer Refractec, Inc. announces post-launch results for CK (Conductive Keratoplasty, the first non-laser procedure for treating farsightedness (hyperopia) in people age 40 and older. A total of 3,860 CK procedures were performed through the first week of October, following CK's approval by the U.S. Food and Drug Administration (FDA) on April 16, 2002. Results were announced at the American Academy of Ophthalmology annual meeting in Orlando.
The CK data was compiled by 54 U.S. physicians who were trained and performed the procedure during CK's introductory period. The three-minute CK procedure uses radio waves, instead of a laser or scalpel, to treat farsightedness; there is no cutting and no removal of tissue. CK is performed in-office with only topical (eye drop) anesthesia.
Following FDA approval, Refractec orchestrated a limited rollout of CK among U.S. ophthalmologists to allow for close monitoring of patient results and to ensure the successful implementation of this new technology by physicians. Refractec's decision to limit the number of physicians offering the CK procedure proved successful.
"The demand for CK has grown at a very rapid pace, compared to past vision correction procedures," said Mitchell B. Campbell, president and CEO of Refractec, Inc. "In under six months, CK physicians have averaged 15 procedures per month -- a milestone which took physicians performing photorefractive keratectomy (PRK) laser surgery more than a year to achieve, after that procedure was introduced in 1995."
The results for CK and corresponding demand for the procedure from physicians and patients, spurred Refractec to step-up its plans for a national rollout. Soon, people nationwide who struggle to read a newspaper, menu or constantly reposition reading material to find the right focus, will have access to a CK physician. Refractec estimates that the number of ophthalmologists offering CK will top 250 by year end, and that it will have trained an additional 100 physicians to perform the procedure by the end of the first quarter 2003. Additionally, the company has tripled its field force to support the increased demand.
"The astounding number of people, especially Baby Boomers, who want a safer alternative to laser surgery has created, and should sustain, a ready market for this procedure," said Daniel S. Durrie, MD, associate clinical professor at the University of Kansas.
Farsightedness is the most common vision disorder in America. It affects more than 60 million Americans -- a full 55 percent of the Baby Boomer generation (those born between 1946 and 1964). Many consider the need for glasses a sign of aging, as they experience increasing difficultly reading a computer screen, an alarm clock, or seeing to drive at night. Yet farsighted procedures comprised only a small percentage of the nearly 2 million U.S. refractive surgeries performed last year. Consumer research shows that, prior to the approval of CK, very few people between the ages of 40 to 60 even considered vision correction surgery, as they tend to be more conservative and risk-adverse than their younger, nearsighted (myopic) counterparts.
According to ophthalmologists, CK has many people reconsidering their vision correction options. "Baby Boomers struggling with the symptoms of farsightedness find CK to be a valuable alternative to constantly reaching for their glasses," said Durrie. "This generation is in their forties and fifties now, and CK is striking a real chord with them. Many of our patients are so anxious to have the CK procedure that they don't want to wait even a few days for their appointment. These are the same patients who considered LASIK too big a risk."
Nearly 95 percent of patients reported being "satisfied" to "extremely satisfied" with their visual outcome post-CK. The CK procedure also provided a restoration to normal vision in 93 percent of patients, according to clinical trial data collected at the 24-month mark post-CK. These outcomes continue to exceed the FDA guideline of 85 percent restoration to normal vision for refractive surgical procedures.
Two-year U.S. clinical data on CK was presented at the Refractive Surgery Interest Group (RSIG) session associated with the AAO meeting. "Although the FDA initially labeled this procedure as temporary, data analysis indicates that patients, on average, are experiencing no significant refractive change between visits at 12 months and 24 months," said Marguerite B. McDonald, MD, professor of ophthalmology at Tulane University, New Orleans, La., and medical monitor for the FDA clinical trials on CK.
"I had been resigned to living with glasses or contact lenses, but still had trouble seeing like I used to," said clinical trial patient, Pamela Larson. "Since having CK in September 2000, my eyesight is back! I haven't needed glasses and can drive at night, track a golf ball and even read my score card without constantly reaching for my glasses."
CK 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. Because the radio waves do not remove tissue from the eye, there is no cutting, which makes CK a very attractive option for many patients.
The minimally invasive CK procedure takes less than three minutes and is done in-office with only topical (eye drop) anesthesia. CK is the first vision correction procedure designed expressly to correct farsightedness. It was approved by the FDA following five years of successful clinical trials in the United States and abroad.
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 technology.
The Refractec Viewpoint CK System received premarket approval for the temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, with less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), and a cycloplegic 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.
CK is an elective procedure with the alternatives including, but not limited to, eyeglasses, contact lenses, photorefractive 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 percent at 3 months, 97 percent at 6 months, 96 percent at 9 months, and 99 percent 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 percent) eyes were corrected to 20/40 or better and 191/344 (56 percent) were corrected to 20/20 or better visual acuity without spectacles or contact lenses.
Long-term risks of CK for hyperopia have not been determined. The safety and effectiveness of re-treatment procedures with the Refractec Viewpoint CK System or other refractive surgical devices have not been established.
Source: Refractec, Inc. and PRNewswire