Corneal Tissue Inlay for Keratoconus

Use of Preserved Corneal Tissue Inlay to Treat Keratoconus

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02649738

Enrollment

Registered

2016-01-07

Start date

2015-12-31

Completion date

2025-12-31

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

keratoconus, corneal tissue inlay

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.

Interventions

PROCEDURECorneal 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal tissue inlay for keratoconus	6 months	Change in maximum keratometry on corneal topography

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026