©2022 Stanford Medicine
Descemet Endothelial Thickness Comparison Trial
Not Recruiting
Trial ID: NCT02373137
Purpose
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.
Official Title
Descemet Endothelial Thickness Comparison Trial
Stanford Investigator(s)
Jennifer Rose-Nussbaumer
Associate Professor of Ophthalmology
Charles C. Lin, MD
Clinical Associate Professor, Ophthalmology
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
Intervention(s):
procedure: DSAEK
procedure: DMEK
device: Endoserter
drug: Prednisolone
drug: Ofloxacin
drug: Tropicamide
drug: Phenylephrine
device: Jones Tube
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305