Descemet Endothelial Thickness Comparison Trial

• Status: Active, not recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University; Winston Chamberlain, MD, PhD
• Collaborators: Stanford University; University of California, San Francisco
• Treatments: Levofloxacin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Ofloxacin; Oxymetazoline; Phenylephrine; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tropicamide

Criteria

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