Status:
UNKNOWN
Gamma-Irradiated Corneal Inlay for Keratoconus
Lead Sponsor:
Cornea and Laser Eye Institute
Conditions:
Keratoconus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 A...
Detailed Description
Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. Preserved corneal tissue is currently available commercially from CorneaG...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04895514
Start Date
February 1 2021
End Date
November 1 2023
Last Update
November 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cornea and Laser Eye Institute, Hersh Vision Group
Teaneck, New Jersey, United States, 07666