Orthokeratology is approved by the FDA in the United States and by Health Canada.
Orthokeratology has been practiced safely for over 20 years. The risks of orthokeratology are generally the same as those of regular contact lens wear. As with regular contact lenses, if ortho-k lenses are not cleaned and cared for according to your doctor's instructions infection may result. Some infections may cause corneal ulcers.
There are very few reported infections with orthokeratology lenses and the infections that have resulted have been due to improper lens care.
Generally, infections related to overnight orthokeratology lens wear should occur less frequently than infections related to regular contact lenses because they are worn for fewer hours. Regular contact lens wearers generally wear their contacts for 12 to 16 hours a day whereas orthokeratology lenses are worn for only the time a person sleeps - generally eight hours. Given their reduced wear-time, orthokeratology lenses are safer than regular contact lenses.
However, proper lens care is a must and patients who are not mature enough to properly care for their lenses should not be treated using orthokeratology.
Orthokeratology has been approved by the FDA and Health Canada as well as the health and medical regulatory bodies of most major countries.