On September 29,2003, Addition Technology, Inc., the maker of Intacs’ (prescription inserts surgical vision correction) received Humanitarian Use Device (HUD) designation for Intacs’ use in certain keratoconus patients in the United States. This is the first of a two-part process in obtaining regulatory approval for a specific product and indication. The next step is the Human Devise Exemption (HDE) approval by the FDA. This means that ophthalmologists will be allowed to put these in corneas of patients with Keratoconus in the United States with the approval of the FDA under the auspices of an institutional IRB (Investigational Review Board). Intacs’ have been used in the treatment of Keratoconus in Europe for the past 5 years on a limited basis in the United States as an off-label procedure for the past 3 years.
     What are Intacs’ and how do they work? Intacs’ are small pieces of plastic that are arc-shaped and are approximately .25 to .35mm in diameter. They are inserted in the cornea at approximately 70% of the depth of the cornea. The procedure, done with anesthetic eye drops, is painless and takes approximately 15 minutes. Intacs’ work by flattening the cornea. This reduces a patient's nearsightedness by shortening the lent of the eye. In fact, Intacs’ were designed and approved in the US to treat –1D to –3D of myopia in normal corneas thorough this flattening effect.
     Joseph Collin in France was the first to use these inserts in patients with Keratoconus. He found in the majority of KC patients he was able to reduce their nearsightedness more than normal patients with nearsightedness because their corneas were thinner and more malleable. 

Most patients, who were contact lens intolerant, became contact lens tolerant and avoided the need of a cornea transplant. An added and somewhat unexpected benefit was that most patients had improved uncorrected and best-corrected visual activity following the implant. Subsequent studies in both Greece and the United States seem to confirm Collin’s initial findings.
     At Laser Eye Associates, Cedars-Sinai Mark Goodson Building, we started performing Intacs’ in patients with Keratoconus on a selected basis approximately 18 months ago. We performed this procedure only on patient who were referred cornea transplants because they were contact lens intolerant and who had no central scarring. In 80% of the patients who we operated on, we were able to avoid the need for a cornea transplant and were able to return them to comfortable contact lens wear with correctible visual activity. The channels needed to insert the Intacs’ are normally made with a mechanical blade-like device carving the channels in the middle of the cornea. Recently, we were fortunate enough to acquire a femtosecond  (Intralase) laser, which allows us to make these channels by laser in an accurate and reproducible manner.  This takes approximately 18 seconds. The complete procedure can now be preformed in a non-traumatic manner in less than 5 minutes.  The patient can then walk out of the procedure with minimal discomfort and resume their normal activity within hours of the procedure. We are very excited about the use of Intacs’ inserted with the femtosecond (Intralase) laser.
     The Intacs’ procedure is very promising and very useful for select patients with Keratoconus. Good candidates are patients who are contact lens intolerant, but want to avoid a cornea transplant. Patients who subsequently need a cornea transplant can still have one since the Intacs’ can be removed without compromising their corneal transplant in any way.

Patients who have Intacs’ procedure have to clearly understand that they will need contact lenses for adequate visual correction. In some instances, they might be happy with only glasses or with soft toric contact lenses. There is no evidence that Intacs’ retard the progression of Keratoconus and this is not a good reason to have the procedure preformed. In fact, most individuals that have Keratoconus and who are over age 40 will most likely not see a progression of their Keratoconus, whether they have Intacs’ or not.
     In the United States, the size of the rings being used are different from the ones approved in Europe and the rest of the world, therefore, results of Intacs’ surgery might not be the same as reports coming from those parts of the world.
     This procedure is undergoing intensive research currently and shows much promise in the future management and treatment in select patients with Keratoconus. In our practice, patients who undergo corneal transplants have excellent results and have potential of becoming independent of contact lenses with LASIK surgery after their transplants .We perform Intacs’ implants for only the 8-10% of patients who are contact lenses intolerant and are candidates for cornea transplants. This number may increase as the technology improves and our research provides refinement to our current technique.