Descemet Endothelial Thickness Comparison Trial

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.

Conditions

• Keratoplasty
• Grafting, Corneal
• Transplantation, Corneal
• Transplantation, Cornea
• Keratoplasty, Lamellar

Interventions

PROCEDURE

DSAEK

PROCEDURE

DMEK

DEVICE

Endoserter

The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.

DRUG

Prednisolone

Prednisolone is a corticosteroid used to alleviate swelling post-surgery.

DRUG

Ofloxacin

Ofloxacin is an antibiotic used to treat bacterial infections of the eye.

DRUG

Tropicamide

Tropicamide is a prescription drug used to dilate pupils during an eye exam.

DRUG

Phenylephrine

Phenylephrine is a prescription drug used to dilate pupils during an eye exam.

DEVICE

Jones Tube

The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Winston Chamberlain, MD, PhD · Oregon Health and Science University

• Jennifer Rose-Nussbaumer, MD · University of California, San Francisco

• Charles Lin, MD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-22

Primary Completion

2018-04-04

Completion

2023-05-30

Countries

• United States

Study Locations