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Corneal Tissue
Gamma-irradiated corneal tissue inlay for Keratoconus
N/A
Waitlist Available
Led By Peter S 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 is testing a new way to treat keratoconus, a eye condition that causes the cornea to thin and bulge. The new treatment involves adding gamma-irradiated corneal tissue to the existing cornea.
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
Gamma-Irradiated Preserved Corneal Tissue Inlay
Secondary outcome measures
Gamma Irradiated Preserved Corneal Tissue Inlay
Trial Design
1Treatment groups
Experimental Treatment
Group I: Corneal tissue inlayExperimental Treatment1 Intervention
The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue
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Who is running the clinical trial?
Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
1,103 Total Patients Enrolled
9 Trials studying Keratoconus
1,103 Patients Enrolled for Keratoconus
Peter S Hersh, MDPrincipal InvestigatorCornea and Laser Eye Institute
4 Previous Clinical Trials
503 Total Patients Enrolled
4 Trials studying Keratoconus
503 Patients Enrolled for Keratoconus
Steven A Greenstein, MDPrincipal InvestigatorCornea and Laser Eye Institute
2 Previous Clinical Trials
330 Total Patients Enrolled
2 Trials studying Keratoconus
330 Patients Enrolled for Keratoconus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Must be at least 18 years old, and can be of any race.The BSCVA is less than or equal to 20/25.or nursing
Do not have to be pregnant or nursing.You have a history of eye conditions that affect the cornea, like herpes infections or corneal diseases.You have had problems with healing in your eye in the past.You have had a previous eye condition, other than needing glasses, that could make it more likely for complications to occur in the eye being treated.You will need to provide written consent and sign a HIPAA form in order to receive treatment.The individual is willing and able to follow all instructions and comply with the schedule for follow-up visits.is associated
Presence of central or inferior steepening on the Pentacam map is associated with a higher risk of progression to glaucoma.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project currently have any openings for volunteers?
"Unfortunately, the clinical trial detailed on clinicialtrials.gov is no longer searching for participants; it was initially posted on February 1st 2021 and its status was last updated November 9th 2022. However, 51 other medical trials are recruiting patients currently."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Cornea and Laser Eye Institute, Hersh Vision Group
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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