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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT05027295
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
* Presence of central or inferior corneal steepening on the Pentacam map
* Axial topography consistent with keratoconus or post-surgical corneal ectasia
* Contact lens wearers only: removal of contact lenses 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 measuring 300 microns or less 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:
1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
2. Clinically significant scarring in the CXL treatment zone
* A history of chemical injury or delayed 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 current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05027295
Study Brief:
Protocol Section:
NCT05027295