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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03813056
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
* Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
* Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
* Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
* The peripheral cornea to the central 6mm is devoid of guttata changes.
* Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.
Exclusion Criteria:
* Uncontrolled glaucoma (IOP \>25 mmHg).
* Presence of secondary corneal pathology such as infective or autoimmune keratitis.
* Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
* History of herpes simplex virus or cytomegalovirus keratitis.
* Prior penetrating keratoplasty.
* Aphakic in study eye.
* Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.
* Tubes or trabeculectomy from prior glaucoma surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
99 Years
Study:
NCT03813056
Study Brief:
Protocol Section:
NCT03813056