Intacs® are clear, thin prescription inserts. Intacs was the first “non-laser” surgical product approved by the U.S. Food and Drug Administration to correct mild amounts of nearsightedness (1 to 3 diopters). Intacs will soon be receiving a Humans Device Exemption from the U.S. FDA for use in keratoconus.

Intacs are inserted into the peripheral cornea. By increasing the volume in the peripheral cornea, there is a flattening in the central portion of the cornea.

Corneal surgeons, including Drs. Clinch, Kang and Shah, noted that the unique characteristics of Intacs make it an excellent alternative to corneal transplantation for some patients with keratoconus. Intacs can be inserted in a brief, relatively painless procedure. The convalescence is measured in weeks rather than months or years.

Unfortunately, not everyone with keratoconus will be a candidate for the Intacs procedure. Our surgeons evaluate patients with keratoconus on a daily basis and can make a determination as to whether you are a candidate.

Arrival and Pre-operative Testing

The Intacs procedure can be performed on an outpatient basis in our Chevy Chase office. You need to arrive at the outpatient surgical suite no later than 45 minutes prior to the procedure. One of our surgeons, or their staff, will review the procedure and answer any questions. The procedure usually takes about 15 minutes per eye. The entire time at the facility is usually about 2 hours.

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The Procedure

The procedure is performed on EDOW surgical suite. It takes approximately 15-30 minutes (see below). We recommend performing surgery on one eye to allow time for convalescence.

A small incision is made in the peripheral cornea with an ultrasonically guided diamond blade or the new Intralase. Then channels are formed in the peripheral cornea, and the Intacs segments are inserted. A micro-thin suture is then placed in the wound. It is removed within the first few weeks.

Radial incision in the cornea

Radial incision in the cornea

Placing the channels

Placing the channels

Inserting the segments

Inserting the segments

Eye with Intacs segments

Eye with Intacs segments

Depending on the degree of keratoconus, the surgeon will use a variety of Intacs segments to attempt to reduce the steep irregular surface. Because the area of greatest thinning is in the lower portion of the cornea, a thicker segment may be placed in the bottom portion and a thinner segment is placed above.

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Post-operative Care

Once the procedure is completed, the patient may return home. During healing, you will need medication drops in your eye.

Visits: You will return to the office on a weekly basis for 1-2 weeks. Your visit schedule will be tailored to your specific needs. A usual regimen would be as follows: post-op day 1, post-op day 7, post-op day 14-28, and then post-op month 2. After the first 1-2 months, the cornea is usually stable enough to prescribe glasses or a contact lens. It is important to understand that the prescription may need to be adjusted several times over the first year as the eye heals.

Medication: The patient is tapered off medications much more quickly than with a corneal transplant. Usually, prednisolone acetate 1.0% is prescribed 4 times per day for the first week then gradually tapered off over the next week. Antibiotic drops are used for the first week and then discontinued. Preservative free artificial tears should be used on a frequent basis (3-6 times/day) for the first several months.

Activity: Unlike with corneal transplantation, the patient may resume most activities very quickly. It is important to be very careful with the eye and follow the instruction sheet carefully. It is critical to wear eye protection at all times during the first week. Most patients may return to work within 1-3 days following surgery; however, activities and vision will be limited in the operated eye until further convalescence.

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Costs of Keratoconus Intacs

The use of Intacs for the surgical correction of keratoconus has not yet received approval by the FDA. There is an abundance of medical literature supporting the use of this technology. EDOW has had success with receiving insurance authorization from several carriers (BlueCross/BlueShield, MD-IPA, etc.); however, carrier to carrier and state to state may differ on the coverage of this procedure. The staff at EDOW will assist in filing a claim for the insertion of the Intacs by doing the following:

  • Prior to the surgery, we submit a letter requesting preliminary review of the procedure.
  • The insurance company will usually respond within 2 to 4 weeks about the coverage of this procedure.
  • If the initial response is favorable, or you wish to proceed without a final insurance approval, we can proceed and schedule your appointment.

Sometimes the response is “this procedure is considered investigational and therefore not covered under your plan.” If this response is received, an appeal will be initiated. The appeal process may take 6 weeks to 1 year and will require some patience and assistance on your part. Several cases have been approved through the appeal process, but there are still several cases pending approval.

For patients who do not have insurance coverage, the fee for surgery is $4,000 per eye.

When submitting to insurance, the fee is separated into two components:

  • Insertion of Intacs (CPT Code 66999): $2,500
  • Lamellar Keratoplasty (CPT Code 65710): $1,000

Financing is available to assist with payment. Please feel free to contact us with any questions or concerns.

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Outcomes

The success of the procedure depends upon the underlying degree of keratoconus. Well over 95% of patients have a significant improvement in their vision, some to 20/20! Most patients will still need to wear glasses or contact lenses to achieve their best visual acuity; however, comfort and/or acuity is far superior. The rate of recovery is variable, usually between 1 month and 6 months, with an average of 2 months.

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Complications and Risks

Since the insertion process is far less invasive than a corneal transplant, both minor side effects and complications are less common. Reported serious side effects are rare but include infection, extrusion of the intacs segments, or loss of vision. Less serious side effects include minor deposits in the cornea, lid drop (Ptosis), and visual disturbances. Intacs® segments can be removed or exchanged in the event of side effects.

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