Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
Condition: Keratoconus; Post-Refractive Ectasia
MeSH terms: Keratoconus; Dilatation, Pathologic
Intervention: Riboflavin; UVX light
Intervention description: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.; UVX 365 nm wavelength light source is applied with continued application of riboflavin.
Intervention MeSH terms: Riboflavin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 510.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Keratoconus; Ectasia; cross linking; collagen cross linking

Summary:

      The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light
      to treat progressive keratoconus or post-refractive corneal ectasia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 10 years of age or older

          2. Having documented ectasia on topography or tomography after previous refractive
             surgery OR progressive keratoconus defined as one or more of the following changes
             over a period of 36 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. Subjects with keratoconus diagnosis only:

             a. Axial topography consistent with keratoconus b. Presence of central or inferior
             steepening on the Pentacam map. c. Presence of one or more slit lamp findings
             associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal
             thinning iv. Corneal scarring

          4. Contact Lens Wearers Only: Removal of contact lenses for the required period of time
             prior to the screening refraction:

             Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week
             Soft Toric 2 Weeks Rigid gas permeable 2 Weeks

          5. Signed written informed consent

        Exclusion Criteria:

          -  1. Any keratoconus patient over 21 years of age without evidence of progression of his
             corneal deformity.

             2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to
             be treated that may predispose the eye for future complications, for example:

             a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis,
             recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. 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.

             7. Pregnancy (including plan to become pregnant) or lactation during the course of the
             study