NCT04895514

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.3 years

First QC Date

May 17, 2021

Last Update Submit

November 9, 2022

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Gamma-Irradiated Preserved Corneal Tissue Inlay

    Change in mean keratometry on corneal topography

    6 months

Secondary Outcomes (4)

  • Gamma Irradiated Preserved Corneal Tissue Inlay

    6 months

  • Gamma Irradiated Preserved Corneal Tissue Inlay

    6 months

  • Gamma Irradiated Preserved Corneal Tissue Inlay

    6 months

  • Gamma Irradiated Preserved Corneal Tissue Inlay

    6 months

Study Arms (1)

Corneal tissue inlay

EXPERIMENTAL

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

Procedure: Gamma-irradiated corneal tissue inlay

Interventions

Gamma-irradiated corneal tissue inlayPROCEDURE

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

Corneal tissue inlay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornea and Laser Eye Institute, Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Peter S Hersh, MD

    Cornea and Laser Eye Institute

    PRINCIPAL INVESTIGATOR

  • Steven A Greenstein, MD

    Cornea and Laser Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2023

Study Completion

November 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

US(1)