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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01604135
Eligibility Criteria:
Inclusion Criteria:
* Keratoconus diagnosis determined clinically and topographically (KISA%- index)
* Significant progression is defined as change (increase) of Kmax by at least
1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation
* Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
* Signed written informed consent
Exclusion Criteria:
* Age \< 18 years
* Pregnancy
* Breast feeding
* History of corneal surgery
* History of ocular herpes simplex infection
* Minimal corneal thickness \< 300 micrometers
* Recurrent corneal erosions
* Other corneal (e g endothelial) or conjunktival diseases
* Neurodermatitis
* Severe forms av atopic disease
* Collagenoses, autoimmune or other systemic disease
* Systemic treatment with high doses of steroids
* Severe scarring och striae of the cornea
Relative exclusion criteria:
* Kmax \> 58D
* Minimal corneal thickness \< 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT01604135
Study Brief:
Protocol Section:
NCT01604135