Corneal Tissue Inlay for Keratoconus

Keratoconus Clinical Trial

Official title:

Use of Preserved Corneal Tissue Inlay to Treat Keratoconus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02649738
• Other study ID #: CLEI-Tissue-Inlay
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Cornea and Laser Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
United States	Cornea and Laser Eye Institue - Hersh Vision Group	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cornea and Laser Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal tissue inlay for keratoconus	Change in maximum keratometry on corneal topography	6 months
Primary	Corneal tissue inlay for keratoconus	Uncorrected visual acuity	6 months
Primary	Corneal tissue inlay for keratoconus	Best spectacle corrected visual acuity	6 months