Back to resultsCorneal Tissue Inlay for Keratoconus
Primary Purpose
Keratoconus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corneal tissue inlay
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, corneal tissue inlay
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age, male or female, of any race
- Provide written informed 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.
Exclusion Criteria:
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- If female, 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 corneal healing in the eye to be treated
- Have used an investigational drug or device within 30 days of the study
Sites / Locations
- Cornea and Laser Eye Institue - Hersh Vision Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corneal tissue inlay
Arm Description
The treated cornea will be implanted with a thin disc of preserved corneal tissue
Outcomes
Primary Outcome Measures
Corneal tissue inlay for keratoconus
Change in maximum keratometry on corneal topography
Corneal tissue inlay for keratoconus
Uncorrected visual acuity
Corneal tissue inlay for keratoconus
Best spectacle corrected visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT02649738
First Posted
January 6, 2016
Last Updated
February 6, 2023
Sponsor
Cornea and Laser Eye Institute
1. Study Identification
Unique Protocol Identification Number
NCT02649738
Brief Title
Corneal Tissue Inlay for Keratoconus
Official Title
Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea and Laser Eye Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.
Detailed Description
The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, corneal tissue inlay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corneal tissue inlay
Arm Type
Experimental
Arm Description
The treated cornea will be implanted with a thin disc of preserved corneal tissue
Intervention Type
Procedure
Intervention Name(s)
Corneal tissue inlay
Intervention Description
A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of preserved corneal tissue will then be placed into the pocket
Primary Outcome Measure Information:
Title
Corneal tissue inlay for keratoconus
Description
Change in maximum keratometry on corneal topography
Time Frame
6 months
Title
Corneal tissue inlay for keratoconus
Description
Uncorrected visual acuity
Time Frame
6 months
Title
Corneal tissue inlay for keratoconus
Description
Best spectacle corrected visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age, male or female, of any race
Provide written informed 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.
Exclusion Criteria:
Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
If female, 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 corneal healing in the eye to be treated
Have used an investigational drug or device within 30 days of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hersh, MD
Organizational Affiliation
Cornea and Laser Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornea and Laser Eye Institue - Hersh Vision Group
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Corneal Tissue Inlay for Keratoconus
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