RECRUITING

Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal. The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.

Official Title

A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy

Quick Facts

Study Start:2019-03-25
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03813056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
  2. * Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
  3. * Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
  4. * Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
  5. * The peripheral cornea to the central 6mm is devoid of guttata changes.
  6. * Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.
  1. * Uncontrolled glaucoma (IOP \>25 mmHg).
  2. * Presence of secondary corneal pathology such as infective or autoimmune keratitis.
  3. * Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
  4. * History of herpes simplex virus or cytomegalovirus keratitis.
  5. * Prior penetrating keratoplasty.
  6. * Aphakic in study eye.
  7. * Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.
  8. * Tubes or trabeculectomy from prior glaucoma surgery.

Contacts and Locations

Study Contact

Alex J Bauer, B.S.
CONTACT
503-413-8377
alex@visiongift.org
Michael D Straiko, M.D.
CONTACT
503-413-8032
mike.straiko@gmail.com

Principal Investigator

Michael D Straiko, M.D.
PRINCIPAL_INVESTIGATOR
Devers Eye Institute

Study Locations (Sites)

Devers Eye Institute
Portland, Oregon, 97210
United States

Collaborators and Investigators

Sponsor: Michael D. Straiko, MD

  • Michael D Straiko, M.D., PRINCIPAL_INVESTIGATOR, Devers Eye Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-25
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2019-03-25
Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Fuchs Endothelial Dystrophy