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Keratoconus

Gamma-Irradiated Corneal Inlay for Keratoconus

Sponsored by Cornea and Laser Eye Institute

About this trial

Last updated 2 years ago

Study ID

GAMMA TISSUE INLAY

Status

Active, not recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status