Keratoconus Treatment with Intacs – Austin Eye

Austin eye offers Intacs for the treatment of keratoconus. We use the IntraLase laser to assist us during the procedure.

For more information please visit www.intacsforkeratoconus.com.

A.  WHAT ARE INTACS® PRESCRIPTION INSERTS?

INTACS prescription inserts were originally approved by the U.S. Food and Drug Administration (FDA) in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). The INTACS inserts are two small, plastic crescents, or arcs, and are made from the same material that has been safely used in contact lenses and cataract surgery for nearly 50 years. INTACS inserts are designed to remain permanently in the eye, yet they can also be removed or replaced, if desired. The INTACS procedure is typically performed in an outpatient setting, using drops to numb your eye.

Additional clinical data have shown that INTACS inserts are safe for the treatment of keratoconus, a disease of the eye.  This degenerative corneal disease is characterized by generalized thinning and a cone-shaped protrusion of the central cornea. This condition usually affects vision in both eyes, although the rates of progression of the disease can be different in each eye. In July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device.

B. WHAT IS A HUMANITARIAN USE DEVICE?

A Humanitarian Use Device is a special category of medical devices that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. Addition Technology, the company responsible for the development and manufacture of INTACS inserts, has received approval from the FDA to market this product in the U.S. as a Humanitarian Use Device for the treatment of keratoconus.

C. WHAT IS KERATOCONUS?

You are being offered the opportunity to consider receiving INTACS inserts because you have been diagnosed with keratoconus, a corneal disease that occurs when the normally round, dome-shaped cornea (the clear outer area of your eye) progressively thins, causing a cone-like bulge to develop. The bulging or “cone-shaped” protrusion is caused by the normal pressure of the eye pushing out on the thinned areas of the cornea. Since the cornea is responsible for refracting most of the light coming into your eye, an abnormally shaped cornea can create reduced visual acuity and affect the way you see. This reduced visual acuity can make even simple daily tasks, such as driving, watching television or reading, difficult to perform. The actual cause of keratoconus is not yet known, but there have been studies to suggest a genetic link to the disease.

D. ARE YOU A GOOD CANDIDATE FOR INTACS PRESCRIPTION INSERTS?

If you are considering INTACS inserts for treatment of keratoconus, you must:

• be at least 21 years of age;
• have nearsightedness and astigmatism as a result of keratoconus;
• be unable to achieve adequate vision correction with contact lenses or glasses;
• have clear central corneas (for example: no scarring or infection present);
• have a corneal transplant procedure as the only remaining option to improve your vision;
• be informed of the risks and benefits as compared to other available treatments for vision correction associated with keratoconus; and
• be willing to sign an informed consent form and to understand that the effectiveness of using INTACS inserts in treating patients with keratoconus has not been established, that the INTACS procedure is likely to only temporarily stop the progression of your keratoconus and that you may still be required to undergo corneal transplantation as the next course of therapy.

E. WHO SHOULD NOT HAVE THE INTACS PROCEDURE?

You should NOT have INTACS inserts placed if:

• you have extensive corneal thinning as a result of your keratoconus;
• you have autoimmune or immunodeficiency diseases (for example: lupus, rheumatoid arthritis, AIDS);
• you are pregnant or nursing;
• you have known conditions of the eye that may increase the likelihood of future problems; or
• you are taking prescription medications, such as Accutane¹ (isotretinoin) or Cordarone² (amiodarone hydrochloride), that may affect corneal healing or your vision. You should discuss all medications you take, even over-the-counter medications, with your eye doctor.
• If you know that you have any of the above conditions, you should inform your doctor. In addition, if you have any other concerns or possible conditions that might affect your decision to have INTACS surgery, you should discuss them with your doctor.

F. DESCRIPTION OF INTACS SURGERY

The two tiny INTACS inserts are surgically placed into the periphery of your cornea through a tiny cut that is made on the cornea after numbing drops have been applied. The IntraLase laser creates a tunnel by separating the tissue layers in the outside periphery of your cornea. The INTACS inserts are placed in the periphery of your cornea much like placing a pencil in between the pages of a book. The INTACS inserts are placed into this tunnel, where they remain. INTACS inserts work by reshaping and adding support to the thinning areas of your cornea to prevent or decrease the forward bulging of your keratoconic cornea. The INTACS inserts cause your cornea to flatten, which will help to better focus light rays onto your retina to achieve clearer vision. The structural support provided by INTACS inserts will also help to create a more regular surface for your cornea, which may allow you to be fitted with contact lenses or glasses again to improve your vision. The primary objective of the Intacs is to improve the shape of your cornea.

G.  WHAT ARE THE BENEFITS?

• INTACS inserts may improve your vision by creating a more regular surface for your cornea, which may allow you to be successfully fitted again with contact lenses, glasses or both.
• INTACS inserts may reduce the nearsightedness and astigmatism associated with your keratoconus.
• INTACS inserts preserve the central part of the cornea, which is most important for your vision.
• INTACS inserts may defer the need for a corneal transplant procedure.
• INTACS inserts can be surgically removed or replaced.

Please contact us at (512) 454-2020 today to learn more about your keratoconus treatment options and/or vision correction with one of our Austin LASIK eye surgeons.

¹ Accutane® is a registered trademark of Hoffman-La Roche Inc.
² Cordarone® is a registered trademark of Sanofi.