FDA APPROVES LASER FOR LASIK

FDA APPROVES LASER FOR LASIK

FDA today approved an eye laser for use in LASIK procedures to correct nearsightedness with or without astigmatism in adults.

LASIK, or laser in-situ keratomileusis, is a non- reversible procedure in which the surgeon uses a knife called a microkeratome to precisely cut a flap in the outer layers of the cornea, removes a small amount of the targeted tissue beneath it with the laser, and then replaces the flap.

The laser, made by Summit Technology of Waltham, Mass., was approved for treating nearsightedness (0.0 to -14.0 diopters) with or without astigmatism (-0.5 to -5.0 diopters) in people 18 and older whose vision has been stable for the past year.

Approval of the laser was based on a review of clinical studies on safety and effectiveness submitted by Summit and on the recommendation of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.

In the studies, LASIK was performed on 1,013 eyes at 13 medical centers in the U.S. Patients were followed for six months.

Of the 1,013 eyes treated, 92 percent were corrected to 20/40 or better and 47 percent were corrected to 20/20 or better without glasses or contact lenses.

Short-term side effects included pain (for 24 to 48 hours), corneal swelling, double vision and light sensitivity. In some patients these effects lasted for several weeks.

Side effects experienced by patients six months after treatment included: under-correction (11.9%); over-correction (4.2%); severe halo (3.5%); loss of best corrected vision with eye glasses (3.0%); severe visual fluctuations (2.6%); and severe glare (1.7%).

Patients with more severe nearsightedness or astigmasitm tended to have poorer visual outcomes. Also, glare and haloes tended to be worse in patients with larger haloes tended to be worse in patients with larger pupil size. Some people who have this procedure will find it more difficult than usual to see in conditions such as very dim light, rain, snow, fog, or glare from bright lights at night.

Pregnant or nursing women or people who have a vascular, auto-immune, or immunodeficiency disease, who have a herpes simplex virus or herpes zoster infection in their eyes, or people taking Accutane for acne or Cordarone to control heart rhythm are not candidates for this treatment.

At FDA’s request, Summit has developed a consumer brochure for people who are considering LASIK surgery. The brochure describes the risks and benefits of the procedure. Summit will provide copies to laser users to give to their patients.

The safety and effectiveness of this procedure have not been established beyond six months.