Intacs� Safety

By: Patricia Woloch
Intacsâ„? are clear, thin slivers like tiny new moons. They are inserted by your eye doctor into the cornea, about two-thirds of the way down into it. That incision is made by a laser or a mechanical separator and no stitches are needed, as it will heal by itself. An Intacs procedure is reversible in that (a) a different size of Intacs can be inserted to replace the original ones; and (b) the Intacs can be removed. Once in the eye, the Intacs are not felt by the person wearing them, and not visible to anyone else.

What Intacs Do

Because of the added thickness Intacs give to the corneal periphery, they change the cornea's curvature, making it flatter. This corrects myopia (nearsightedness) as long as it is not too severe. They are an alternative to LASIK for correcting myopia, but not often used for that purpose.

Keratoconus

They are also an excellent treatment for keratoconus. Keratoconus is a condition where the cornea is too thin and weak to maintain its curvature against the eye's internal pressure - the fluids which press outwards on the eye's periphery. It bulges forward, distorting vision. Intacs correct for that bulge, restoring a flatter curvature which gives clearer vision.

Intacs After LASIK or PRK

A rare problem after laser vision correction is corneal ectasia. The cornea becomes thinner and irregular in its contour and vision deteriorates. Glasses or contact lenses are sometimes helpful for a while only, as this is a progressive condition. Intacs can help by smoothing out the corneal irregularities.

Intacs Safety Record

As with any surgical procedure, an Intacs placement brings a certain risk. But because they can be removed, Intacs have an excellent safety record. Their size can be changed, and no additional incisions are needed. Or they can be removed and not replaced. The tiny incision is outside the visual field and so cannot impair vision.

The FDA approved Intacs in 2004 for keratoconus patients with myopia and astigmatism. They attached certain limitations on their use, so they are not available for:

? Pregnant or nursing women

? Anyone with an autoimmune disease

? Anyone taking certain medications

? Patients with corneal thickness below 449 microns

The FDA also issued some warnings to eye doctors about patients with certain eye conditions and about techniques of inserting Intacs. Because the FDA approved Intacs under The Humanitarian Device Exemption, they did not do the very large Phase 3 studies involving thousands of participants. Phase 2 studies were done, with several hundred participants, but this means that there are some unknowns about long-term Intacs efficacy and safety. Studies were started at the time of approval and are ongoing.

Intacs so far have an outstanding safety record, and if you are wondering whether they'd be a good option for you, the first thing to do is choose a . You would want a doctor who screens his patients carefully, communicates well with patients, and has several years of Intacs experience.

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