Know the Risks of Intacs

I would like patients to know that Intacs is not necessarily the answer to their problems. There are risks involved with Intacs surgery. In a recent issue of Ophthalmology Management magazine, there was an advertisement by Intacs with the following contraindications, warnings and precautions as required by the FDA.

Contraindications: Intacs Corneal Implants for keratoconus are contraindicated:

• 1. In patients who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site.
• 2. In patients with collagen vascular, autoimmune or immunodeficiency diseases.
• 3. In pregnant or nursing women
• 4. In the presence of ocular conditions such as recurrent corneal erosion syndrome or corneal dystrophy, that may predispose the patient to future complications.
• 5. In patients who are taking certain specific medications which may interfere with the eye healing following Intacs surgery.

Warnings:

• 1. Some patients with large pupils are predisposed to low light visual symptoms post-operatively and should be appropriately advised.
• 2. The long term effect of Intacs Corneal Implants on endothelial cell density has not been established.
• 3. In low light conditions, patients may experience some loss of contrast sensitivity.
• 4. The safety of Intacs Corneal Implants for keratoconus have NOT been established:
• • a. In patients with progressive myopia or astigmatism, cataracts, corneal abnormaliities, or or previous corneal surgery or trauma.
  • b. For patients under 21years of age.
  • c. For corneas with a central corneal thickness of less than 480 microns.
  • d. In long term use.

The images below show an eye before and after intacs removal. The third image shows an eye rejecting intacs. The last image shows GVR scleral lens over a cornea with Intacs. Note how irregular the Intacs cornea is.