UG1EY030417

Descemet Endothelial Thickness Comparison Trial (DETECT) - Project Summary/Abstract

Although endothelial keratoplasty is one of the most commonly performed transplant surgeries, it is unknown which technique provides optimal visual acuity outcomes while minimizing endothelial cell loss and complications. Post-operative endothelial cell counts have been shown to correlate with the risk of subsequent graft failure, resulting in significant costs to individual patients and society.

Topical Rho-kinase inhibitors, such as Ripasudil 0.4%, may play an important role in maintaining endothelial health after keratoplasty. Here, we propose the Descemet Endothelial Thickness Comparison Trial (DETECT), a randomized, outcome-masked, multi-center, four-arm clinical trial with a 2x2 factorial design.

The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries: Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). Additionally, we aim to determine the effect of Rho-kinase inhibitors on endothelial cell counts after keratoplasty.

Patients presenting to Oregon Health & Science University, Stanford University, Northshore University HealthSystem, University of Maryland, and Kaiser Permanente Northern California with endothelial dysfunction who are good candidates for either UT-DSAEK or DMEK will be eligible for inclusion.

Participants will be randomized to one of four treatment groups in this 2x2 factorial design study:

1. Endothelial Keratoplasty
a. UT-DSAEK
b. DMEK

2. Adjuvant Topical Medication
a. Ripasudil 0.4%
b. Placebo

The innovative aspects of this approach include testing a novel treatment, Ripasudil 0.4%, and the randomization of surgery, which is relatively rare. It aligns with the priorities of the National Eye Institute (NEI) by studying new high-resolution imaging techniques, such as endothelial cell imaging, anterior-segment optical coherence, and Pentacam Scheimpflug imaging, to guide post-operative treatment and serve as potential surrogate trial endpoints in future trials.

This world-class team of collaborators has a proven track record for executing large NEI-funded trials in ophthalmology and is well-positioned to answer the two important questions presented in this proposal.

The Leland Stanford Junior University

1) TO SUPPORT EYE AND VISION RESEARCH PROJECTS THAT ADDRESS THE LEADING CAUSES OF BLINDNESS AND IMPAIRED VISION IN THE U.S. THESE INCLUDE RETINAL DISEASES, CORNEAL DISEASES, CATARACT, GLAUCOMA AND OPTIC NEUROPATHIES, STRABISMUS, AMBLYOPIA, AND LOW VISION AND BLINDNESS REHABILITATION. 2) TO INCREASE UNDERSTANDING OF THE NORMAL DEVELOPMENT AND FUNCTION OF THE VISUAL SYSTEM IN ORDER TO BETTER PREVENT, DIAGNOSE, AND TREAT SIGHT-THREATENING CONDITIONS, AND, TO ENHANCE THE REHABILITATION, TRAINING, AND QUALITY OF LIFE OF INDIVIDUALS WHO ARE PARTIALLY-SIGHTED OR BLIND. 3) TO SUPPORT A BROAD PROGRAM OF BASIC VISION RESEARCH THROUGH GRANTS AND COOPERATIVE AGREEMENTS, TO ENCOURAGE HIGH QUALITY CLINICAL RESEARCH, INCLUDING CLINICAL TRIALS, OTHER EPIDEMIOLOGICAL STUDIES, AND HEALTH SERVICES RESEARCH, TO ENCOURAGE RESEARCH TRAINING AND CAREER DEVELOPMENT IN THE SCIENCES RELATED TO VISION, AND TO SPONSOR SCIENTIFIC WORKSHOPS IN HIGH PRIORITY RESEARCH AREAS TO ENCOURAGE EXCHANGE OF INFORMATION AMONG SCIENTISTS. 4) SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO ENCOURAGE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.867 - Vision Research

National Eye Institute (NEI) [HHS - NIH]

Palo Alto, California 943033225 United States

Single Zip Code

NEI Collaborative Clinical Vision Research : Chair's Grant (UG1-Clinical Trial Required) (PAR-18-523)

Amendment Since initial award the total obligations have increased 443% from $1,053,760 to $5,726,406.