Gamma-Irradiated Corneal Inlay for Keratoconus

This is an interventional treatment trial for Keratoconus Read More

Inclusion Criteria:

• At least 18 years of age, male or female, of any race
• Provide written consent and sign a HIPAA form
• Willingness and ability to follow all instructions and comply with schedule for follow-up visits
• For females: must not be pregnant

• Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following:

  • Moderate Keratoconus: Axial topography consistent with keratoconus, Maximum keratometry on Pentacam greater than or equal to 51.01 D
  • Severe Keratoconus: Axial topography consistent with keratoconus with marked areas of steepening, Maximum keratometry on Pentacam greater than or equal to 56.01 D
• Presence of central or inferior steepening on the Pentacam map
• BSCVA less than or equal to 20/25
• Contact lens wearers only: remove contact lenses one week prior to the screening refraction

Exclusion Criteria:

• Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
• If female, be pregnant
• Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme

• Previous ocular condition (other than refractive error) in the eye 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, corneal melt, corneal dystrophy, etc.)

• A history of delayed epithelial healing in the eye to be treated
• Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study