Gamma-Irradiated Corneal Inlay for Keratoconus

NCT ID: NCT04895514

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-11-01

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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corneal tissue inlay

The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue

Group Type: EXPERIMENTAL

Gamma-irradiated corneal tissue inlay

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornea and Laser Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter S Hersh, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea and Laser Eye Institute

Steven A Greenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea and Laser Eye Institute

Locations

Cornea and Laser Eye Institute, Hersh Vision Group

Teaneck, New Jersey, United States

Countries

United States

Other Identifiers

GAMMA TISSUE INLAY

Identifier Type: -

Identifier Source: org_study_id