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FDA has approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision. The device is called CustomVue Monovision LASIK.

LASIK, or Laser-Assisted In Situ Keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the clear covering of the front of the eye (cornea), removes a small amount of the tissue beneath it with the laser, and then replaces the flap.

Monovision is a corrective technique used to treat people with presbyopia, which is normal age-related loss of the ability to focus on near objects. The intent is for the person to use one eye for distance viewing and one eye for near viewing.

"Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people over 40," says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. Who’s It For

CustomVue Monovision LASIK produces monovision correction in nearsighted (myopic) adults, with or without an abnormal curve of the cornea (astigmatism), ages 40 years or older with presbyopia. How it Works

The CustomVue device is designed to correct all nearsightedness in a person's dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the person to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes. Factors to Consider

People considering CustomVue Monovision LASIK should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye under-corrected. Following monovision surgery, both eyes may not work together as well as they did before in some people, 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

CustomVue Monovision LASIK is a permanent operation to the cornea. Side effects may include:

• glare from bright lights
• rings around lights (halos)
• light sensitivity
• night driving glare
• ghost images
• double vision
• visual fluctuation

Follow-up Study

FDA based its approval on the review of a clinical study of safety and effectiveness outcomes submitted by the manufacturer, AMO/VISX Inc., Santa Clara, Calif.

At FDA's request, AMO/VISX will conduct a post-approval study. The study will follow 500 people for six months after surgery to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect their quality of life.

Date posted: July 17, 2007

VISX CustomVue WaveScan and Lowry Ophthalmology Offer You A New Level of Safety and Vision Quality

VISX announced on May 23, 2003 that it received approval from the US Food and Drug Administration (FDA) for CustomVue^TM laser vision correction, with the potential to enable better vision than with contacts or glasses.

The CustomVue procedure tailors a unique correction for each individual. It employs the VISX WaveScan^® System, a new diagnostic system that captures a "fingerprint" of the eye which is 25 times more precise than what was previously measurable by standard methods for glasses and contact lenses. WaveScan evaluates more than nearsightedness, farsightedness, and astigmatism; it captures other, more specific imperfections in each individual's vision. This data is then used to generate an individualized treatment for a CustomVue procedure.

FDA clinical study data presented at the 2003 ASCRS Symposium showed that at one year following the procedure, 98% of the clinical study participants could see 20/20 or better UCVA, while nearly 70% had either the same or better post-op UCVA compared to their pre-op BSCVA. A six-month evaluation of the clinical study participants showed that four times as many participants were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts.

Reprinted from VISXPRESS (VISX Corp. newsletter) Issue #132, May 27, 2003

As part of their commitment to the Triangle's vision needs, Lowry Ophthalmology is proud to announce that Dr. Lowry is among the first doctors in North Carolina to be certified in this procedure which provides a new dimension in safety and quality of vision. Lowry Ophthalmology continues to take the lead in providing the safest and most precise vision correction.