NEW YORK, Oct 22 (Reuters Health) -- The US Food and Drug Administration (FDA) has approved the LASIK (laser in-situ keratomileusis) eye laser for use in correcting myopia (nearsightedness) with or without astigmatism in adults.
The LASIK system involves a microkeratome knife to create a flap in the cornea to remove a small amount of tissue underneath. After surgery, the flap is replaced.
The laser, manufactured by Summit Technology of Waltham, Massachusetts, is approved for the treatment of myopia up to -14.0 diopters that may be accompanied by astigmatism of -0.5 to -5.0 diopters in individuals over the age of 18 with vision that has been stable for at least one year.
Approval was based on studies of 1,013 eyes treated at 13 medical centers. Overall, 92% were corrected to 20/40 or better and 47% were corrected to 20/20 or better.
Adverse effects were pain lasting 24 to 48 hours, under-correction of vision in 11.9%, over-correction in 4.2%, severe halo in 3.5%, loss of best corrected vision with glasses or contact lenses in 3.0%, severe visual fluctuation in 2.6%, and severe glare in 1.7%. Patients with the most severe myopia and astigmatism experienced the poorest outcomes.
Contraindications for the LASIK procedure are pregnancy or breastfeeding; vascular, auto-immune or immunodeficiency disease; and herpes simplex virus or herpes zoster infection of the eyes; or those on either Accutane for acne or Cordarone for cardiac arrhythmia.
The FDA has asked Summit to develop a brochure for consumers to explain the risks and benefits of the procedure.
