In 1994 the FDA granted the first ever daily wear approval for a lens
indicated for Orthokeratology to a type of lens called the Contex
OK-Lens. A significant milestone for the United States market
occurred in June 2002 when the FDA granted approval for overnight
wear of a type of corneal reshaping called "Corneal Refractive
Therapy" (CRT). This forms the basis of the "Paragon CRT" product
backed by Paragon Vision Sciences Inc. Subsequently in 2004, the
U.S. Food and Drug Administration (FDA) approved a design from
Euclid Systems Corporation ("Emerald"). Each FDA approval has a
Premarket approval (PMA) number. The PMA number of the FDA approval
for Paragon CRT is P870024; the PMA number of the FDA approval for
Emerald is P010062.
Ortho-K (orthokeratology) is a nonsurgical eye treatment using specially designed contact lenses to gently reshape the curvature of the eye while you sleep to improve vision. Ortho-K retainer contact lenses are made of highly oxygen permeable material allowing for safe wear while you sleep.
Ortho-K corneal refractive therapy lenses only affect the cornea of the eye. The cornea shape is critical in maintaining a sharp optical focus on objects by bending the light that enters the eye. The cornea is the clear part of the eye that covers the iris and the pupil. The corneal tissue is soft and can be subtly molded. The Ortho-k lenses float on your eye tear film, yet provide enough pressure reshape the cornea. The iSee™ Ortho-K therapy lenses gently reshape the first few microns of the cornea while you sleep.
Once the lenses are removed in the morning, the slight change in the curvature of the corneal surface results in clear vision during waking hours, thus reducing the need of daytime contact lenses or glasses. With iSee™ Ortho-K corneal refractive therapy contact lenses, 20/20 vision can be restored in as little as one day to a few weeks. The best part is that iSee™ cornea refractive therapy is safe, non-surgical, non-invasive and reversible.