Status:
RECRUITING
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
Lead Sponsor:
Michael D. Straiko, MD
Collaborating Sponsors:
Lions VisionGift Research
Eye Bank Association of America
Conditions:
Fuchs Endothelial Dystrophy
Eligibility:
All Genders
30-99 years
Phase:
PHASE2
Brief Summary
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03813056
Start Date
March 25 2019
End Date
February 1 2025
Last Update
March 20 2024
Active Locations (1)
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1
Devers Eye Institute
Portland, Oregon, United States, 97210