Descemet Endothelial Thickness Comparison Trial
Status unconfirmed · Phase 4
Conditions studied: Keratoplasty, Grafting, Corneal, Transplantation, Corneal, Transplantation, Cornea, Keratoplasty, Lamellar
In brief
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.
Key facts
- Study ID
- NCT02373137
- Run by
- Oregon Health and Science University
- People needed
- 38
- Starts
- 2015-01-22
- Expected to finish
- 2023-05-30
- Last updated by the study team
- 2020-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Byers Eye Institute, Stanford University — Palo Alto, California, United States
- F. I. Proctor Foundation, University of California, San Francisco — San Francisco, California, United States
- Casey Eye Institute, Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.