Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2015-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Corneal tissue inlay
The treated cornea will be implanted with a thin disc of preserved corneal tissue
Corneal 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
Interventions
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Corneal 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cornea and Laser Eye Institute
OTHER
Responsible Party
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Principal Investigators
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Peter Hersh, MD
Role: PRINCIPAL_INVESTIGATOR
Cornea and Laser Eye Institute
Locations
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Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey, United States
Countries
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References
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Greenstein SA, Yu AS, Gelles JD, Eshraghi H, Hersh PS. Corneal tissue addition keratoplasty: new intrastromal inlay procedure for keratoconus using femtosecond laser-shaped preserved corneal tissue. J Cataract Refract Surg. 2023 Jul 1;49(7):740-746. doi: 10.1097/j.jcrs.0000000000001187.
Other Identifiers
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CLEI-Tissue-Inlay
Identifier Type: -
Identifier Source: org_study_id
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