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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT04897503
Eligibility Criteria:
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 week prior to the screening refraction
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria:
* Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
* Corneal pachymetry less than or equal to 300 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, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL 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 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:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04897503
Study Brief:
Protocol Section:
NCT04897503