Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty
Condition: Fuchs' Endothelial Dystrophy; Cataract
MeSH terms: Cataract; Fuchs' Endothelial Dystrophy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary aim of the study is to determine whether a rho kinase inhibitor, Netarsudil, can
      speed corneal clearance after DWEK. Secondary aim of the study is to investigate whether
      patient factors, such as baseline age, pachymetry, or endothelial cell count influence
      response to Netarsudil.
    

Detailed description: 
      Spontaneous corneal clearance after Descemetorhexis without keratoplasty (DWEK) has been
      documented in several previous trials. One of the largest cohorts at Massachusetts Eye and
      Ear Infirmary demonstrated spontaneous corneal clearance in about 82% of cases but mean time
      to clearance was approximately three months after the procedure. During this time period,
      patients have significantly reduced central vision. Furthermore, some patients fail to have
      corneal clearance even eight months after DWEK and have to undergo Descemet membrane
      endothelial keratoplasty (DMEK) to achieve corneal clearance. A recent international case
      report has documents that the addition of a rho kinase inhibitor, Ripasudil, to two eyes that
      failed to clear by two to three months after DWEK resulted in corneal clearance within two
      weeks after the addition of Ripasudil. This finding indicates the possibility that a rho
      kinase inhibitor can be used to speed corneal clearance after purposeful Descemetorhexis. The
      only FDA approved rho kinase inhibitor eye drop currently available is Netarsudil, approved
      in December of 2017 for use in ocular hypertension and primary open angle glaucoma.
      Investigating whether Netarsudil can speed corneal clearance after DWEK is truly importance
      as the potential to expand patient eligibility for DWEK is significant. Both patients that
      had previously not wanted to wait approximately three months after the procedure for corneal
      clearance as well as patients with lower mid-peripheral endothelial cell counts may now be
      eligible for a procedure to treat corneal endothelial dysfunction without a corneal
      transplant. This would reduce risks for corneal transplant rejection and failure, reduce need
      for long-term steroid eye drop use, and reduce need for frequent corneal screenings to ensure
      transplant health.

      The current study aims to investigate whether the off-label use of Netarsudil can improve
      corneal clearance after DWEK in Fuchs endothelial dystrophy patients.
    

Intervention name(s): Netarsudil 0.02% Ophthalmic Solution
Intervention type(s): Drug
Intervention description(s): Use of Netarsudil 0.02% ophthalmic solution daily after surgery
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a pilot study to determine whether there is any benefit to using Netarsudil after DWEK surgery. The study plans to enroll 10 patients (20 eyes) with Fuchs endothelial dystrophy and cataract to under combined cataract surgery with DWEK sequentially in both eyes. The first eye will be treated with Netarsudil after surgery and time to clearance will be noted. The second eye will not be treated with Netarsudil and if time to clearance is longer than the first eye, Netarsudil will be added to test if it can be used as a "rescue" drop.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DWEK, Netarsudil