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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT05870566
Eligibility Criteria:
Inclusion Criteria:
Medical condition or disease to be investigated:
\- Pathologically prevascularized cornea with need for corneal transplantation
Further inclusion criteria:
* Written informed consent by subject and/or witness prior to any study-related procedures
* Adult male and female subjects ≥ 18 years old
* ≥ 2 corneal quadrants covered by pathological corneal neovascularization
* Absence of other clinical contraindications to any part or product of the treatment plan
* A cooperative attitude to follow up the study procedures
* In case of bilateral disease only one eye will be included
* Steroid responders with adequate control regiment or local/systemic therapy can be included
Exclusion Criteria:
* \< 2 corneal quadrants covered by pathological neovascularization
* Corneal stromal thickness below 400 μm (except in the central 8 mm zone which will be replaced later by a new corneal transplant with new endothelium); peripheral stromal thinning below 400 μm in weakened recipient areas is acceptable for CXL if not affecting more than 50% of the corneal circumference (allowing for later endothelial repopulation)
* Active or suspected intraocular inflammation
* Active corneal ulceration
* Compromised eyelid mobility and/or symblepharon
* Allergy, sensitivity or intolerance to riboflavin or UV
* Contraindications, other than steroid response to the local or systemic antibiotics and/or corticosteroids (other than steroid response) foreseen by the protocol
* Contraindications to the surgical protocol
* Clinically significant or unstable concurrent disease or other medical condition affecting grafting procedure
* Rheumatic diseases treated with systemic immunosuppressive medication
* Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments
* Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit
* Positive for human immunodeficiency virus (HIV)
* Known abuse of alcohol, drugs, or medicinal products
* Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the subject's compliance, or place the subject at high risk of complications related to the treatment
* Employees of the sponsor, or employees or relatives of the investigator.
* Pregnant women and nursing mothers as corneal transplantation in standard care is performed under general anaesthesia
* Persons held in an institution by legal or official order
* Dysregulated glaucoma with IOP \> 25 mmHg at baseline despite local therapy
(Protocol V04\_0 Page 43)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05870566
Study Brief:
Protocol Section:
NCT05870566