Gamma-Irradiated Corneal Inlay for Keratoconus

Keratoconus Clinical Trial

Official title:

Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04895514
• Other study ID #: GAMMA TISSUE INLAY
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2022
• Source: Cornea and Laser Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
United States	Cornea and Laser Eye Institute, Hersh Vision Group	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cornea and Laser Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gamma-Irradiated Preserved Corneal Tissue Inlay	Change in mean keratometry on corneal topography	6 months
Secondary	Gamma Irradiated Preserved Corneal Tissue Inlay	Inferior-Superior (I-S) ratio	6 months
Secondary	Gamma Irradiated Preserved Corneal Tissue Inlay	Manifest refraction	6 months
Secondary	Gamma Irradiated Preserved Corneal Tissue Inlay	Uncorrected distance visual acuity	6 months
Secondary	Gamma Irradiated Preserved Corneal Tissue Inlay	Best spectacle corrected distance visual acuity	6 months