Trial Search Results

Descemet Endothelial Thickness Comparison Trial

The purpose of this study is to compare visual acuity outcomes of two types of endothelial keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2) Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be randomized to have DSAEK and the other half will have DMEK.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Oregon Health and Science University

Collaborator: University of California, San Francisco

Stanford Investigator(s):

Intervention(s):

  • Procedure: DSAEK
  • Procedure: DMEK
  • Device: Endoserter
  • Drug: Prednisolone
  • Drug: Ofloxacin
  • Drug: Tropicamide
  • Drug: Phenylephrine
  • Device: Jones Tube

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   - Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy

   - Good candidates for corneal transplantation for either DMEK or DSAEK

   - Willingness and ability to undergo a cornea transplantation

   - Willingness to participate in follow-up visits

Exclusion Criteria:

   - Participants who are decisionally and/or cognitively impaired

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

   - Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except
   uncomplicated cataract surgery

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

   - Presence of a condition that increases the probability for failure (e.g., heavily
   vascularized cornea, uncontrolled uveitis)

   - Other primary endothelial dysfunction conditions including posterior polymorphous
   corneal dystrophy and congenital hereditary corneal dystrophy

   - Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or
   anticipated during EK

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

   - Hypotony (Intraocular pressure <10mmHg)

   - Uncontrolled (defined as intraocular pressure >25mmHg) glaucoma Visually significant
   optic nerve or macular pathology

   - Visually significant optic nerve or macular pathology

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
Not Recruiting