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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    72
  • sponsor
    Michael D. Straiko, MD
Updated on 12 September 2021

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 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.

Details
Condition Fuchs' endothelial dystrophy
Treatment Descemet Membrane Endothelial Keratoplasty, Optive, Ophthalmic Solution, Glanatec
Clinical Study IdentifierNCT03813056
SponsorMichael D. Straiko, MD
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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
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