Evaluation and diffusion of excimer laser treatment of myopia in the United States and in The Netherlands.

Excimer laser photorefractive keratectomy (PRK) is an experimental treatment to correct myopia (short-sightedness) that is diffusing into use without convincing evidence of safety and efficacy. It has been claimed that PRK may render conventional methods of correcting myopia, such as wearing glasses or contact lenses, obsolete. Since about 25% of the world's population is myopic, the consequences of this technology in terms of benefits, risks, and costs could be truly enormous. The fee for the procedure in various countries such as the United States, the Netherlands, and Australia varies from about US $1500 to US $2250 per eye. In the United States, the Food and Drug Administration, acting as authorized in the Medical Devices Act of 1976, has limited the use of PRK to patients participating in clinical trials. In the Netherlands, in contrast, where medical equipment is not regulated, the method has diffused without controls, although it is not reimbursed by health insurance agencies. The procedure has become controversial in the Netherlands because it is provided privately and has been aggressively and inappropriately promoted. The case illustrates the limitations of health policy concerning technologies provided privately and raises a number of social and political questions.