Is Intacs® an FDA-Approved Alternative to a Corneal Transplant for Keratoconus?

Updated

Intacs® Corneal Implants are described on intacsforkeratoconus.com as the only FDA-approved intracorneal segments, and they are intended to reduce or eliminate myopia and astigmatism in patients with keratoconus so that functional vision may be restored and a corneal transplant potentially deferred. They are not a replacement for a transplant in every case: the site positions them as an option to consider before a cornea transplant, and suitability must be confirmed with an eye care professional.

What Intacs® are and what they are designed to do

According to the site, Intacs® are ophthalmic medical devices made from polymethylmethacrylate (PMMA) and are available in different thicknesses. When placed in the corneal stroma outside the central optical zone, they are designed to reshape and stabilize the cornea.

The stated goals are to:

  • Reduce or eliminate myopia and astigmatism in patients with keratoconus
  • Restore functional vision
  • Potentially defer the need for a corneal transplant procedure

How they are inserted, and whether they can be removed

The site states that Intacs® segments are designed to be placed in the periphery of the cornea at approximately two-thirds depth and are surgically inserted through a small radial incision in the corneal stroma. The devices are also designed to allow removal or replacement.

Question What the site states
Where are they placed? Periphery of the cornea, about two-thirds depth, outside the central optical zone
How are they inserted? Surgically, through a small radial incision in the corneal stroma
Can they be removed? Yes — designed to allow removal or replacement
Material PMMA, available in different thicknesses

Keratoconus and why an implant is considered

Keratoconus is described as a disease that thins the cornea and causes it to progressively bulge into a cone-like shape. That change in shape can have a dramatic impact on vision. Intacs® are presented as a possible way to improve vision before considering a cornea transplant.

How to decide whether this path applies to you

The site does not publish patient selection criteria, candidacy requirements, or outcome data beyond the general description above. The practical next step is therefore a consultation with an eye care professional who can assess your cornea and tell you whether Intacs® is appropriate for your situation or whether a corneal transplant or another approach is more suitable.

For general background, the site's own framing is the clearest guide: Intacs® are intended to potentially defer — not universally replace — a corneal transplant.