Corneal Tissue Inlay for Keratoconus

Cornea and Laser Eye Institute

Status

Active, not recruiting

Conditions

Keratoconus

Treatments

Procedure: Corneal tissue inlay

Study type

Interventional

Funder types

Other

Identifiers

NCT02649738

CLEI-Tissue-Inlay

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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