Last updated: December 30, 2022
Sponsor: Cornea and Laser Eye Institute
Overall Status: Active - Recruiting
Phase
3
Condition
Vision Loss
Eye Disease
Treatment
N/AClinical Study ID
NCT04897503
CLEI - ISO-CXL-001
Ages > 12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-surgical corneal ectasia
- Contact lens wearers only: removal of contact lens for the required period of 1 weekprior to the screening refraction
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion
Exclusion Criteria:
- Eyes classified as either normal, atypical normal, or keratoconus suspect on theseverity grading scheme
- Corneal pachymetry less than or equal to 300 microns at the thinnest point measured byPentacam in the eye(s) to be treated
- Previous ocular condition (other than refractive error) in the eye(s) to be treatedthat may predispose the eye for future complications, for example: History of cornealdisease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome,corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in theCXL treatment zone
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- Pregnancy (including plan to become pregnant) or lactation during the course of thestudy
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze duringthe CXL treatment or other diagnostic tests
- Patients with a current condition that, in the investigator's opinion, would interferewith or prolong epithelial healing
Study Design
Total Participants: 170
Study Start date:
April 16, 2021
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey 07666
United StatesActive - Recruiting
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