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

Launched by MICHAEL D. STRAIKO, MD · Jan 19, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the use of Ripasudil, a medication that helps improve eye health, in patients with Fuchs Endothelial Dystrophy who are undergoing a specific eye surgery called Descemet Membrane Endothelial Keratoplasty (DMEK). The aim is to see if using Ripasudil after the surgery can help the eye heal faster and reduce swelling more effectively, leading to better vision and fewer complications.

To participate in this study, you need to have a confirmed diagnosis of Fuchs endothelial corneal dystrophy with certain levels of vision impairment. Eligible participants include individuals with specific types of eye lenses and grades of the condition. However, some people may not qualify if they have uncontrolled glaucoma or other serious eye issues. If you decide to join, you can expect regular check-ups and care to monitor how well the treatment works for your recovery. This trial is currently looking for participants, and your involvement could help improve treatments for others with similar conditions in the future.

Gender

ALL

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.