Gamma-Irradiated Corneal Inlay for Keratoconus

Status unconfirmed · Not applicable

Conditions studied: Keratoconus

In brief

Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).

Key facts

Study ID

NCT04895514

Run by

Cornea and Laser Eye Institute

People needed

10

Starts

2021-02-01

Expected to finish

2023-11-01

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornea and Laser Eye Institute, Hersh Vision Group — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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