Corneal Tissue Inlay for Keratoconus

February 6, 2023 updated by: Cornea and Laser Eye Institute

Use of Preserved Corneal Tissue Inlay to Treat Keratoconus

This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Cornea and Laser Eye Institue - Hersh Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Corneal tissue inlay
The treated cornea will be implanted with a thin disc of preserved corneal tissue
Procedure: Corneal tissue inlay
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal tissue inlay for keratoconus
Time Frame: 6 months
Change in maximum keratometry on corneal topography
6 months
Corneal tissue inlay for keratoconus
Time Frame: 6 months
Uncorrected visual acuity
6 months
Corneal tissue inlay for keratoconus
Time Frame: 6 months
Best spectacle corrected visual acuity
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornea and Laser Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (ESTIMATE)

January 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEI-Tissue-Inlay

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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