WesternU conducts studies for FDA approval of tomography equipment
Western University of Health Sciences continues to enhance its reputation as a leader in imaging studies as it conducts studies on an Optical Coherence Tomography (OCT) device for approval from the U.S. Food and Drug Administration.
WesternU’s College of Optometry is conducting an agreement and precision trial and a normative reference database trial for the Topcon OCT-1 Maestro. Topcon Corporation is a Tokyo, Japan-based company divided into three business domains: Smart Infrastructure, Positioning and Eye Care.
WesternU is the sole U.S. site conducting the agreement and precision trial, and one of seven institutions involved in the normative reference database. Investigators from all seven institutions met recently at WesternU.
The trials, which began in March and will continue until June 2015, require patients 18 years and older in three categories: healthy, diagnosed with glaucoma, and diagnosed with retinal diseases.
The grant budget is $140,000. College of Optometry Professor Pinakin G. Davey, OD, PhD, is the Principal Investigator.
“We are building a reputation as a research entity for imaging,” Davey said. “We have done FDA studies for Optovue, and we are increasing our partnering with Topcon, which is putting us in the right light for more of these studies to come in.”
Topcon is proud to work with WesternU for FDA approval of its newest OCT imaging device, said Michael J. Sinai, PhD, Senior Manager, Global Product Planning, Topcon Corporation Eye Care Company.
“This new device is the latest in OCT technology and will improve the capability of clinicians to detect and monitor eye diseases,” he said. “WesternU was chosen along with other prestigious institutions because of its positive track record to produce high-quality research. In particular, Dr. Pinakin Davey has been instrumental in the success of our study. His hard work and dedication have made WesternU a great institution for collaboration between industry and academia. Topcon would like to thank WesternU and Dr. Davey for the success of this important study.”
The WesternU Team for these studies includes Davey; Jennifer Kurtz; Jessica Lee, MS; Joshua Cameron, PhD; Naida Jakirlic, OD; Munish Sharma, MD, OD; and Guru Sharma, OD, PhD.
“These kinds of trials put us in the forefront of developing technology,” Davey said. “We can improve our collaboration with industry and get certain bench-to-bedside ideas out there and implemented.”
