Corneal Tissue Inlay for Keratoconus

Not Applicable

Active, not recruiting

• Conditions: Keratoconus
• Interventions: Procedure: Corneal tissue inlay

• Registration Number: NCT02649738
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Status Verified: 2022-12
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corneal tissue inlay	Corneal tissue inlay	The treated cornea will be implanted with a thin disc of preserved corneal tissue

Primary Outcome Measures

Name	Time	Method
Corneal tissue inlay for keratoconus	6 months	Best spectacle corrected visual acuity

Trial Locations

Locations (1)

Cornea and Laser Eye Institue - Hersh Vision Group; 🇺🇸 Teaneck, New Jersey, United States