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FDA Approves Monovision Lasik

Already common technique to reduce the need of reading glasses approved by FDA.


FDA approves already common monovision Lasik.

July 12, 2007 -- The US Food and Drug Administration today approved monovision Lasik. Monovision is the process of correcting one eye for distance vision and one eye for near vision to reduce the need for reading glasses or bifocals for patients affected by presbyopia - the inability of the eye to focus on near objects. For most people the brain adjusts to the difference in perception between the two eyes. Monovision can be provided with contact lenses or laser eye surgery.

Monovision is already available as an off-label use of the Lasik laser. An off-label use is when a medical device already approved for one procedure is used for another. Off-label use is a common method by which doctors put medical devices to the best use for patients.

"Monovision Lasik has been available off-label since approval of the first laser used for conventional Lasik laser eye surgery," says Glenn Hagele, Executive Director of the Council for Refractive Surgery Quality Assurance (, a nonprofit Lasik patient advocacy. "This FDA approval is not likely to have any practical effect on the availability of monovision Lasik in the United States, however patients can now have monovision with the more advanced custom wavefront technology."

Custom wavefront Lasik creates a more accurate "fingerprint" of the patient's vision to guide the laser during surgery, commonly resulting in a more accurate outcome.

According to the FDA, people considering monovision Lasik should first wear monovision contact lenses to determine if they can tolerate having one eye under-corrected. Following monovision surgery, the two eyes may not work together as well as they did before in some patients, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small type. Side effects may include glare from bright lights, rings around lights (halos), light sensitivity, night driving glare, ghost images, double vision and visual fluctuation.

Lasik, or laser in-situ keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with the laser, and then replaces the flap.

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