Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT01464268
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
* Vision with contact lenses or glasses is worse than 20/20
* Corneal thickness greater than 375 microns at the thinnest point
Exclusion Criteria:
* Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
* Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
* Clinically significant corneal scarring in the CXL treatment zone
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01464268
Study Brief:
Protocol Section:
NCT01464268