"Intacs™ for keratoconus

Keratoconus is a multifactoral eye disease which can result in frustration and visual deficiency for some patients. The circular front window of the eye is called the cornea, and it often becomes misshapen with keratoconus. The resulting irregularity can create visual distortion that cannot be corrected with glasses. Often a rigid contact lens is required to compensate for the corneal irregularity. If such a lens does not work or if the individual cannot comfortably tolerate the lens, the next step is often surgery.

Corneal transplantation used to be the only surgery available for keratoconus. Now, however, Intacs™ surgery is available. Some surgeons prefer Intacs™ for keratoconus because it is less invasive than a cornea transplant. In fact, the FDA has recently labeled Intacs™ for use in keratoconus.

The goal of Intacs™ in keratoconus is not to remove the need for corrective lenses. The goal of Intacs™ is to permit good visual correction with glasses or to allow a switch from a hard contact lens to a more comfortable soft contact lens. The Intacs™ segments tend to smooth the irregular cornea in keratoconus thus improving the optics.

The original work in Intacs™ for keratoconus was done by Drs. Colin and Cochner in France. Dr. Fleming performed the first Intacs™ surgery for keratoconus in the United States.

Intacs™ after LASIK or PRK

LASIK and PRK (photorefractive keratectomy) have been done in large numbers worldwide. Most people have good results from these procedures. A small percentage of patients may have problems after these laser procedures that can be helped by Intacs™. First, LASIK and PRK may not fully correct an individual's nearsightedness. Intacs™ may be helpful in correcting the remaining nearsightedness. Second, LASIK or PRK can result in a condition known as ectasia. This problem can result in marked worsening of vision, and Intacs™ can be successful in restoring functional vision.

After LASIK or PRK, some patients will not obtain full correction of their nearsightedness, or an initial full correction may regress to only a partial correction. Usually an effort is made to correct this residual myopia with a second laser treatment (enhancement). However, in some patients additional laser may be deemed unsafe and those individuals will need glasses. For these instances Intacs™ may be useful to correct the leftover nearsightedness and free the individual of corrective lenses. Dr. Fleming performed the world's first Intacs™ procedure for this purpose in a patient who had previous LASIK. The procedure was performed in 1999 in Milan, Italy, and reported in the year 2000 in the Journal of Refractive Surgery (coauthored with Dr. Carlo Lovisolo).

Ectasia is a problem that can occur after LASIK or PRK and is related to large amounts of corneal tissue removal by the laser. With ectasia, the cornea becomes irregular and misshapen. Often vision cannot be adequately corrected even with contact lenses or glasses. Prior to the advent of Intacs™, a patient's only surgical recourse was a corneal transplant. Intacs™, however, can help smooth the irregular ectatic cornea and allow visual improvement . Dr. Fleming coauthored (with Dr. Lovisolo as the primary author) one of the first reports on Intacs™ for ectasia in 2002.

Intacs™ for Nearsightedness

Intacs™ surgery for correction of nearsightedness (myopia) was approved by the FDA in 1999. It is used to treat lower levels of nearsightedness. Although the success rate of Intacs™ is similar to that of LASIK, it is not as well known because LASIK treats a broader range of myopia. For those individuals in the lower range of nearsightedness, however, Intacs™ surgery brings certain unique features and advantages. Unlike laser, which is permanent, Intacs™ segments may be removed or exchanged. Also, Intacs™ surgery does not result in permanent tissue removal as does laser.

The insertion of Intacs™ segments in the cornea causes corneal flattening and reduction of nearsightedness. The procedure is done with just eyedrop anesthesia and takes about 10-12 minutes. Intacs™ may be done in the doctor's office or in a conventional operating room. All surgical procedures can have complications, but the complication rate with Intacs™ is low.

Data taken from patients undergoing Intacs™ surgery in the Phase II and Phase III FDA trials give an indication of the success rate in treating nearsightedness. Two years after surgery, vision without glasses was 20/40 or better in 97%, 20/20 or better in 76%, and 20/16 or better in 55%.

Intacs™ for Ectasia

Ectasia is a difficult problem in a very small percentage of people who have undergone LASIK or PRK. These individuals often do well immediately following the laser procedure, but over time visual problems develop. Glasses or contact lenses may initially help, but eventually vision becomes poor even with corrective lenses.

Ectasia results in progressive thinning and distortion of the cornea after laser treatment. Likewise, attainment of useful vision becomes more and more difficult. Severe corneal ectasia may ultimately lead to the need for a corneal transplant. Intacs™, however, can be useful in restoring functional vision in ectatic eyes. The presence of the Intacs™ segments (which are implanted in the ectatic cornea) tends to smooth the distortion and irregularity.

Dr. Fleming coauthored (with Dr. Carlo Lovisolo as primary author) one of the first scientific articles on Intacs™ for ectasia in the year 2000.

Risks of Intacs™ Surgery

The U.S. Food and Drug Administration approved the use of Intacs™ for treatment of myopia only after studying the safety record of Intacs™ done in hundreds of patients. The safety record on Intacs™ has been good. Intacs™, like all surgical procedures, can result in complications, but the rate is low. The fact that Intacs™ segments can be removed with reversal of the refractive effect contributes to the Intacs™ safety record.

Dr. Fleming discusses the risks of Intacs™ surgery in detail with each patient before the procedure.

What is Intacs™ surgery like?

In most instances Intacs™ insertion takes about 10 minutes per eye. Usually only eyedrop anesthesia is needed. No eye injections or injections around the eye are needed. Depending upon the desires of the surgeon and the patient, the procedure may be done in the office or in an operating room. In many ways the experience of having Intacs™ surgery is similar to having LASIK.

Most individuals have minimal if any discomfort while having Intacs™ procedure. Afterwards, the individual uses eyedrops for about two weeks. The Intacs™ patient is generally examined the day after insertion and again about one week later. Additional visits are scheduled according to routine.