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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Corneal tissue inlay for keratoconus
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study instructions and attend all follow-up visits.I have been diagnosed with moderate or severe keratoconus.I am not pregnant.I have had an eye condition before that could cause future problems.My eye has had slow healing from a previous injury or surgery.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Corneal tissue inlay
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Keratoconus Patient Testimony for trial: Trial Name: NCT02649738 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum participant count for this clinical trial?
"Affirmative. The information presented on clinicaltrials.gov shows that this study, which was initially published on December 1st 2015, is currently recruiting participants. 20 patients are being sought out from one medical centre for the trial."
Answered by AI
Is recruitment for this research project open to new participants?
"Affirmative. According to data posted on clinicaltrials.gov, this research project is open for recruitment and was first announced on December 1st 2015. The study requires 20 participants between one medical site and the details were last updated on March 7th 2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Cornea and Laser Eye Institue - Hersh Vision Group
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Virginia
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How often are screening visits/how long?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I've had kerataconus since my early 20s and I'm looking for ways to improve my eyesight besides contacts.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Cornea and Laser Eye Institue - Hersh Vision Group: < 24 hours
Average response time
- < 1 Day
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