Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

The purpose of this is to ascertain the possible additive effect of the two treatments to
both improve the quality of the corneal optics (i.e. improve corneal topography regularity)
and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed,
does improve corneal topography and improve contact lens tolerance and spectacle corrected
visual acuity, as well as uncorrected visual acuity in some patients. Investigations of CXL
have shown the procedure not only to decrease keratoconus progression, but also to decrease
the steepness of the cone and improve uncorrected and best corrected visual acuity in some
cases. Since the mechanism of improvement differs between the procedures, this suggests a
potential additive effect of the two on the patient's ultimate visual outcome. Thus, the
patient would be afforded two potential benefits: (1) the potential of a more robust visual
outcome and (2) stabilization of the keratoconic cornea on the longer term.

Inclusion Criteria:

- 21 years of age or older

- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
(e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)

- Subjects who meet the manufacturer's nomogram recommendations for Intacs segments

- Topography consistent with keratoconus or post-surgical corneal ectasia.

- BSCVA worse than 20/20 (<55 letters on ETDRS chart)

Exclusion Criteria:

- Eyes classified as either normal, atypical normal, or keratoconus suspect on the
severity grading scheme.

- Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the
eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns
when the hypotonic riboflavin us used, provided that the corneal thickness after
treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry
≤ 450 microns at the proposed insertion site for the Intacs

- Previous ocular condition (other than refractive error) in the eye(s) to be treated
that may predispose the eye for future complications

- History of corneal disease

- History of chemical injury or delayed epithelial healing in the eye(s) to be treated.

- Pregnancy (including plan to become pregnant) or lactation during the course of the
study

- A known sensitivity to study medications

- Subjects with nystagmus or any other condition that would prevent a steady gaze during
the CXL and Intacs treatment or other diagnostic tests.

- Subjects with a current condition that, in the investigator's opinion, would interfere
with or prolong epithelial healing.