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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01789333
Eligibility Criteria:
Inclusion Criteria:
Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
1. 16 years of age or older
2. Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
1. Characteristic pattern of deformity as analyzed by the Pentacam map.
2. Minimal thickness of 350 microns
3. The ability to sign a written informed consent
4. States a willingness and ability to comply with schedule for follow-up visits
5. Subject willing to remove contact lenses prior to evaluation and treatment
Inclusion criteria for ectasia
1. History of having undergone a keratorefractive procedure and show:
1. Steepening by Pentacam study
2. Thinning of cornea
3. Shift in the position of thinnest portion of cornea
4. Unstable refraction with increasing myopia and astigmatism
5. Development of irregular astigmatism
2. At least two of the above criteria must be present.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from this study:
Subjects meeting any of the following criteria will be excluded from this protocol:
1. Eyes classified as either normal or atypical normal,
2. Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
3. A history of delayed epithelial healing.
4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
5. A known sensitivity to study medications
6. Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
7. Inability to cooperate with diagnostic tests.
8. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
9. Patients who are unable to remain supine and tolerate a lid speculum.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01789333
Study Brief:
Protocol Section:
NCT01789333