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):

Intervention(s):

  • Drug: Topical Ripasudil
  • Drug: Topical Placebo

Phase:

Phase 3

Eligibility


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
   assessment

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Varnado, MPH
4802981310
Not Recruiting