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Intacs are thin plastic, semi-circular rings inserted into the mid layer of the cornea. When inserted in the keratoconus cornea they flatten the cornea, changing the shape and location of the cone. The placement of Intacs remodels and reinforces the cornea, eliminating some or all of the irregularities caused by keratoconus in order to provide improved vision. This can improve uncorrected vision, however, depending on the severity of the KC, glasses or contact lenses may still be needed for functional vision.

FDA Approval

Intacs were approved under a Humanitarian Device Exemption (HDE) by the FDA in July 2004, allowing Intacs to be used for treating keratoconus. As part of the HDE approval, Addition Technology, the manufacturer of Intacs, has implemented an extensive training program in which each surgeon will be required to participate.

What is a Humanitarian Device Exemption (HDE)?

The humanitarian device regulations were first established in October 1994. Humanitarian Use Devices (HUDs) are medical devices specially designated by the FDA for use in the treatment of fewer than 4000 patients per year with rare medical conditions. CPT Code is: Category III CPT code 0099T

Intacs received a Category III CPT code 0099T from the American Medical Association. Category III CPT codes are temporary codes to designate emerging technologies and are not assigned a value. It is up to the insurance company to determine the amount to be paid. A Category III code has 5 years to become mainstream, whereupon it may be promoted to a permanent Category I code.

The Procedure

This procedure involves placing the plastic inserts just beneath the surface of the eye in the periphery of the cornea. The procedure itself takes approximately 15 to 20 minutes usually in the doctor’s office. Topical anesthetic drops are used to numb the eye, and a clamp is used to hold the eye open throughout the procedure to prevent blinking. There are 3 basic steps to the procedure:

Step 1: A single, small incision is made in the surface of the cornea. Instead of using mechanical cutting, some surgeons may use a laser to make the incision.

Step 2: A centering guide is placed on the surface of the eye for several minutes to help stabilize the eye and ensure proper alignment of the Intacs insert. During this time, the corneal layers are gently separated in a narrow circular band on the outer edge where the Intacs will be placed.

Step 3: The Intacs inserts are placed. Once this insertion is completed, the small opening in the cornea is closed with a suture.

Follow-up visits will be required to monitor the healing process and to evaluate the visual benefits of the procedure. Even after a successful procedure, glasses or contacts may be required.

As with any surgical procedure, there are some risks, including infection. Some patients experience visual symptoms including difficulty with night vision, glare, halos, blurry and fluctuating vision.