Gamma-Irradiated Corneal Inlay for Keratoconus

Sponsor
Cornea and Laser Eye Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04895514
Collaborator
(none)
10
1
1
21
0.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gamma-irradiated corneal tissue inlay
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gamma-Irradiated Preserved Corneal Tissue Inlay [6 months]

    Change in mean keratometry on corneal topography

Secondary Outcome Measures

  1. Gamma Irradiated Preserved Corneal Tissue Inlay [6 months]

    Inferior-Superior (I-S) ratio

  2. Gamma Irradiated Preserved Corneal Tissue Inlay [6 months]

    Manifest refraction

  3. Gamma Irradiated Preserved Corneal Tissue Inlay [6 months]

    Uncorrected distance visual acuity

  4. Gamma Irradiated Preserved Corneal Tissue Inlay [6 months]

    Best spectacle corrected distance visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
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

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:

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cornea and Laser Eye Institute, Hersh Vision Group Teaneck New Jersey United States 07666

Sponsors and Collaborators

  • Cornea and Laser Eye Institute

Investigators

  • Principal Investigator: Peter S Hersh, MD, Cornea and Laser Eye Institute
  • Principal Investigator: Steven A Greenstein, MD, Cornea and Laser Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:
NCT04895514
Other Study ID Numbers:
  • GAMMA TISSUE INLAY
First Posted:
May 20, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022