Gamma-Irradiated Corneal Inlay for Keratoconus

Not Applicable

Active, not recruiting

• Conditions: Keratoconus
• Interventions: Procedure: Gamma-irradiated corneal tissue inlay

• Registration Number: NCT04895514
• Lead Sponsor: Cornea and Laser Eye Institute

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 Addition for Keratoconus (CTAK).

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 Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-06-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corneal tissue inlay	Gamma-irradiated corneal tissue inlay	The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue

Primary Outcome Measures

Name	Time	Method
Gamma-Irradiated Preserved Corneal Tissue Inlay	6 months	Change in mean keratometry on corneal topography

Secondary Outcome Measures

Name	Time	Method
Gamma Irradiated Preserved Corneal Tissue Inlay	6 months	Best spectacle corrected distance visual acuity

Trial Locations

Locations (1)

Cornea and Laser Eye Institute, Hersh Vision Group; 🇺🇸 Teaneck, New Jersey, United States