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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Rho kinase Inhibitor
artificial tears (placebo)
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Devers Eye Institute
Portland, Oregon, United States
RECRUITINGTime to corneal clearance
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
Time frame: 6 months
Best corrected visual acuity
Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
Time frame: 6 months
Endothelial cell density
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
Time frame: 6 months
Post surgery complications
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
Time frame: 6 months
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