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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
No Placebo-Only Group
Summary
This trial uses sterilized corneal tissue to treat patients with keratoconus. The added tissue helps make the cornea thicker and more stable, improving vision.
Eligible Conditions
- Keratoconus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gamma-Irradiated Preserved Corneal Tissue Inlay
Secondary study objectives
Gamma Irradiated Preserved Corneal Tissue Inlay
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 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.
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