Fuchs Endothelial Dystrophy
Conditions
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 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.
Interventions
DRUGGlanatec
Rho kinase Inhibitor
artificial tears (placebo)
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Sponsors
Lions VisionGift Research
Eye Bank Association of America
Michael D. Straiko, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to corneal clearance | 6 months | Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 6 months | Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units. |
| Endothelial cell density | 6 months | Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss. |
| Post surgery complications | 6 months | Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded. |
Countries
United States
Contacts
Primary ContactAlex J Bauer, B.S.
Backup ContactMichael D Straiko, M.D.
Outcome results
None listed