Trial Search Results

Descemet Endothelial Thickness Comparison Trial I

Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Oregon Health and Science University

Stanford Investigator(s):


  • Drug: Topical Ripasudil
  • Drug: Topical Placebo


Phase 3


Inclusion Criteria:

   - Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata
   extending beyond 4.5 mm of the central cornea

   - Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal
   Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior
   Polymorphous Corneal Dystrophy (PPMD)

   - Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or
   without systemic immunosuppression)

   - Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt
   without ongoing hypotony (IOP < 5 mmHg)

   - Good candidate for corneal transplantation for either DMEK or UT-DSAEK

   - Prior graft failure after PKP or EK

   - Willingness and ability to undergo corneal transplantation

   - Willingness to consistently use study medications (i.e. ROCK-inhibitors)

   - Willingness to participate in follow-up visits

   - Age greater than 18 years

Exclusion Criteria:

   - Uncontrolled uveitis

   - Aphakia, or anterior chamber IOL in study eye prior to or anticipated during EK

   - Pre-operative central sub-epithelial or stromal scarring that the investigator
   believes is visually significant and could impact post-operative stromal clarity

   - Peripheral anterior synechiae (iris to angle) in the angle greater than a total of
   three clock hours

   - Uncontrolled glaucoma (IOP >25 mmHg)

   - Visually significant optic nerve (ok to have small visual field defects) or macular
   severe pathology

   - Participants who are not suitable for the DMEK or UT-DSAEK surgeries

   - Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal
   dystrophies and scars)

   - Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber
   IOL at time of study EK

   - Hypotony (Intraocular pressure <10mmHg)

   - Inability to comply with post-operative instructions (i.e. unable to position)

   - Participants who are decisionally and/or cognitively impaired

   - Pregnancy

   - Fellow eye visual acuity <20/200

   - Children (18 years and under)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Varnado, MPH
Not Recruiting