Gamma-Irradiated Corneal Inlay for Keratoconus

Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Procedure: Gamma-irradiated corneal tissue inlay

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 CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such tissue is currently used in a number of eye surgical procedures. It is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Cornea and Laser Eye Institute, Hersh Vision Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Corneal tissue inlay; The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue	Procedure: Gamma-irradiated corneal tissue inlay; A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gamma-Irradiated Preserved Corneal Tissue Inlay	Change in mean keratometry on corneal topography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gamma Irradiated Preserved Corneal Tissue Inlay	Inferior-Superior (I-S) ratio	6 months
Gamma Irradiated Preserved Corneal Tissue Inlay	Manifest refraction	6 months
Gamma Irradiated Preserved Corneal Tissue Inlay	Uncorrected distance visual acuity	6 months
Gamma Irradiated Preserved Corneal Tissue Inlay	Best spectacle corrected distance visual acuity	6 months

Collaborators and Investigators

• Sponsor: Cornea and Laser Eye Institute
• Investigators: Principal Investigator: Steven A Greenstein, MD, Cornea and Laser Eye Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: GAMMA TISSUE INLAY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No