Non-Surgical Procedure Does Not Cure Bad Vision
Ads claiming that an eye care treatment called "Precise Corneal Molding" orthokeratology ("PCM ortho-k") can cure vision deficiencies are false and unsubstantiated, the Federal Trade Commission alleged today in announcing a settlement with a Tennessee eye doctor who is a primary source of the treatment. PCM ortho-k is an eye care service that purports to eliminate dependence on eyeglasses and contact lenses. It is marketed as a non-surgical alternative to surgical eye procedures such as laser PRK (photorefractive keratectomy) and RK (radial keratotomy). According to the FTC, J. Mason Hurt, O.D., falsely claimed that PCM ortho-k can cure vision deficiencies permanently. The settlement would prohibit Hurt from making any false claims and would require reliable scientific evidence for any success or efficacy claims.
"Consumers have the right to expect that ads are truthful and nowhere is this more important than in matters concerning health and safety," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "No one should be allowed to lure consumers into undertaking eye treatments that don't deliver as promised."
PCM ortho-k uses a series of contact lenses purportedly to reshape the cornea gradually to correct nearsightedness, farsightedness, and astigmatism. Four academic studies published in the late 1970's and early 1980's examined questions of whether contact lenses could be used to reshape the cornea and lessen or eliminate the need for corrective eyewear. These studies found only a very small decrease in nearsightedness that would not eliminate the need for eyewear for most patients. Further, the reduction is only temporary because the cornea tends to regain its original shape upon lens removal.
According to the FTC, Hurt and his corporations, Mid-South PCM Group, P.C., Eye and Vision Clinic, P.C., and the International Computerized Orthokeratology Society, Inc., promote their eye treatment through the use of Internet, print, radio and television advertisements; free consultations; videos; brochures; and pamphlets, which are provided directly to consumers and to other optometrists across the country. Hurt also sells the right to promote and perform PCM ortho-k through "training seminars" where optometrists are trained to perform the procedure.
The FTC's complaint charges that Hurt made false and misleading claims that:
- PCM ortho-k provides a cure for any refractive vision deficiency and can permanently eliminate the need for glasses and contact lenses.
- PCM ortho-k has been approved by the Federal Aviation Administration and all branches of the U.S. military for use in correcting refractive vision deficiencies.
- Studies at the University of Houston College of Optometry, University of California at San Diego Medical School, University of California at Berkeley College of Optometry, and Pacific University College of Optometry prove that PCM ortho-k is safe and effective in correcting nearsightedness, farsightedness, and astigmatism.
- Testimonials from consumers appearing in the ads reflect the typical or ordinary experience of members of the public; those who receive the services achieve 20/20 vision and no longer need corrective eyewear.
The complaint also alleges that Hurt made unsubstantiated claims that: (1) a significant number of people can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear PCM ortho-k devices occasionally or at night; (2) all or most people will experience stabilized vision after only a few weeks or months of PCM ortho-k treatments; (3) PCM ortho-k prevents and reverses deteriorating nearsightedness in children; (4) PCM ortho-k is safer than contact lenswear; (5) PCM ortho-k is more effective than refractive surgical methods in eliminating nearsightedness, farsightedness, and all forms of astigmatism; and (6) PCM ortho-k has helped thousands of people achieve normal vision.
In order to resolve the charges, Hurt would be prohibited from claiming that PCM ortho-k or any substantially similar service provides a cure for vision deficiencies; that all people can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear devices used with such services occasionally or at night; that the four academic studies prove PCM ortho-k is safe and effective in correcting nearsightedness, farsightedness, and astigmatism; and that PCM ortho-k has been approved by the FAA and all branches of the military.
In addition, the settlement would require, for PCM or any substantially similar service, that Hurt possess and rely upon reliable scientific evidence for claims about: the number of people who can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear devices used with such service occasionally or at night; the number of people who will experience stabilized vision after only a few weeks or months of treatments under such service; the ability of such service to prevent or reverse deteriorating nearsightedness in children; the comparative safety of such service and contact lens wear; the comparative effectiveness of such service and refractive surgical methods in eliminating nearsightedness, farsightedness, or any form of astigmatism; and the number of people whom such service has helped achieve normal vision.
The settlement also would prohibit Hurt from representing that his treatment is endorsed by any governmental or professional entity unless it is true or from using any testimonial of a typical experience unless either: it is true and substantiated or is accompanied by a disclosure that describes what results program participants could expect or states that counsumers should not expect to achieve similar results. The settlement also prohibits any misrepresentions of study results.
Hurt also could not send to any eye care provider any material containing claims prohibited under the settlement. In addition, he would be required to send a notice to each optometrist with whom he has done business requesting that any of his materials that violate the settlement not be used and to terminate any optometrist's right to market and/or perform PCM ortho-k if any ad or promotion restricted by the settlement is disseminated.
Finally, the order contains various record keeping requirements that would assist the FTC in monitoring compliance.
FTC staff members also have been working with the Food and Drug Administration on questions raised by Hurt's use of contact lenses for reshaping the cornea. The FDA has issued a letter to Hurt et al. warning that the contact lenses (or "molds") used for overnight wear in the Precise Corneal Molding (PCM) procedure have not been approved as safe and effective for commercial use.
The investigation of Hurt and his corporations was conducted with the assistance of the offices of the Attorneys General of several states which are conducting investigations into the promotion of ortho-k.
The Commission vote to accept the proposed consent agreement for public comment was 5-0.
An analysis of the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 60 days, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaint, proposed consent agreement and an analysis of the agreement to assist the public in commenting will be available on the Internet at the FTC's World Wide Web site at: http://www.ftc.gov or by calling 202-326-3627. FTC documents also are available from the FTC's Public Reference Branch, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 1-866-653-4261. To find out the latest news as it is announced, call the FTC's NewsPhone recording at 202-326-2710.
(FTC File No. 9623279)
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