Corneal Tissue Inlay for Keratoconus

Status unconfirmed · Not applicable

Conditions studied: Keratoconus

In brief

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

Key facts

Study ID

NCT02649738

Run by

Cornea and Laser Eye Institute

People needed

20

Starts

2015-12-01

Expected to finish

2025-12-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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