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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06451718
Eligibility Criteria:
Inclusion Criteria:
* Male and female ≥ 18 years old
* Not suitable for ICRS and are recommended for keratoplasty
* Best distance spectacle corrected visual acuity (BDCSVA) 1.30 - 0.40 logMAR (0.05-0,40 decimal notation)
* Have stable or stabilized disease for 12 months (in case of cross-linking, it must have been done 12 months prior to intervention)
* Have a KC stage 3-4 (Amsler-Krumeich) with a Central K readings \> 53.00 D and RMS of coma aberration \> 3.5.
* Signed and dated informed consent form
Exclusion Criteria:
* Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent
* Untreated progressive KC
* Single functioning eye
* Minimum Corneal thickness \< 400 μm
* Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking
* Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal investigator may be contraindicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06451718
Study Brief:
Protocol Section:
NCT06451718