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Corneal Tissue Inlay

Corneal Tissue Inlay for Keratoconus

N/A
Waitlist Available
Led By Peter Hersh, MD
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
If female, pregnant
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.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether placing preserved corneal tissue in a keratoconic cornea will improve thickness, stability, and optics.

Who is the study for?
This trial is for adults with moderate to severe keratoconus, a condition that affects the cornea of the eye. Participants must be willing to follow instructions and attend follow-up visits. Women cannot be pregnant to join. People with allergies to trial materials, mild or suspected keratoconus, history of slow corneal healing, other significant eye conditions, or recent participation in other trials are excluded.
What is being tested?
The study tests placing preserved corneal tissue into the affected cornea of patients with keratoconus. The goal is to improve thickness and stability of the cornea and correct its shape for better vision.
What are the potential side effects?
Potential side effects may include discomfort at the site where tissue is added, risk of infection from surgery, possible allergic reactions if sensitive to materials used in procedure, and delayed healing which could lead to further complications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant.
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I have had an eye condition before that could cause future problems.
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My eye has had slow healing from a previous injury or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corneal tissue inlay for keratoconus

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Corneal tissue inlayExperimental Treatment1 Intervention
The treated cornea will be implanted with a thin disc of preserved corneal tissue

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Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
1,093 Total Patients Enrolled
9 Trials studying Keratoconus
1,093 Patients Enrolled for Keratoconus
Peter Hersh, MDPrincipal InvestigatorCornea and Laser Eye Institute
5 Previous Clinical Trials
597 Total Patients Enrolled
3 Trials studying Keratoconus
467 Patients Enrolled for Keratoconus

Media Library

Corneal tissue inlay (Corneal Tissue Inlay) Clinical Trial Eligibility Overview. Trial Name: NCT02649738 — N/A
Keratoconus Research Study Groups: Corneal tissue inlay
Keratoconus Clinical Trial 2023: Corneal tissue inlay Highlights & Side Effects. Trial Name: NCT02649738 — N/A
Corneal tissue inlay (Corneal Tissue Inlay) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649738 — N/A
Keratoconus Patient Testimony for trial: Trial Name: NCT02649738 — N/A
~2 spots leftby Dec 2025
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