Keratoconus and Ectasia Treatment Plan (Compassionate)

Inclusion Criteria:

Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment:

For Keratoconus and Ectasia:

1. 18 years of age or older

2. Having a diagnosis of progressive keratoconus defined as one or more of the following changes over a period of 24 months or less before randomization:

   1. An increase of >; 1.00 D in the steepest keratometry value (or sim K)
   2. An increase of >; 1.00 D in regular astigmatism evaluated by subjective manifest refraction
   3. A myopic shift (decrease in the spherical equivalent) of > 0.50 D on subjective manifest refraction
   4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
3. Presence of central or inferior steepening on the Pentacam map.
4. Axial topography consistent with keratoconus

5. Presence of one or more slit lamp findings associated with keratoconus, such as:

   • Fleischer ring
   • Vogt striae
   • Corneal thinning
   • Corneal scarring

6. Contact Lens Wearers Only:

   1. Removal of contact lenses are required prior to the screening-Contact Lens 7. Signed written informed consent

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this treatment:

1. No evidence of progression.
2. Excessively thin corneas.

3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:

   1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
   2. Clinically significant corneal scarring in the proposed treatment zone
4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
5. A known sensitivity to treatment medications
6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.