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Trial record 1 of 12 for:    hersh | Teaneck, New Jersey, U.S.
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Corneal Tissue Inlay for Keratoconus

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ClinicalTrials.gov Identifier: NCT02649738
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Cornea and Laser Eye Institute

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.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Corneal tissue inlay Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Corneal tissue inlay for keratoconus [ Time Frame: 6 months ]
    Change in maximum keratometry on corneal topography

  2. Corneal tissue inlay for keratoconus [ Time Frame: 6 months ]
    Uncorrected visual acuity

  3. Corneal tissue inlay for keratoconus [ Time Frame: 6 months ]
    Best spectacle corrected visual acuity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649738


Locations
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United States, New Jersey
Cornea and Laser Eye Institue - Hersh Vision Group Recruiting
Teaneck, New Jersey, United States, 07666
Contact: BethAnn Furlong-Hibbert, BA    201-883-0505    bfurlong-hibbert@vision-institute.com   
Contact: Stacey Lazar, BS    201-883-0505    slazar@vision-institute.com   
Principal Investigator: Peter S Hersh, MD         
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
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Principal Investigator: Peter Hersh, MD Cornea and Laser Eye Institute
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Responsible Party: Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier: NCT02649738    
Other Study ID Numbers: CLEI-Tissue-Inlay
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Keywords provided by Cornea and Laser Eye Institute:
keratoconus
corneal tissue inlay
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases