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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT04198350
Eligibility Criteria:
Inclusion Criteria:
* T1D participants that fulfill criteria for islet transplantation
* Systemic immunosuppression
* At least one eye with VA from HM to 0.1, and fellow eye with equal or better VA
* Age ≥ 18 years
* Normal cornea with good visualization of the anterior segment
* Participant not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation
* Participants who have recently been involved in research or who are actively involved in research may be recruited at the discretion of the chief investigator if the active research has no impact on glucose self-management.
Exclusion Criteria:
* VA below HM or above 0.1
* Neovascular glaucoma
* Iris neovascularization
* Ongoing treatment with intraocular anti-VEGF or steroids (and no injection within 4 weeks) in the study eye and no anticipated need for therapy during study period.
* Ongoing retinal laser photocoagulation
* Signs of current infection or inflammation
* Intraocular surgery within 3 months
* Previous or planned anterior segment surgery for glaucoma
* Poor visualization of the anterior chamber
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04198350
Study Brief:
Protocol Section:
NCT04198350