Clinical Trial Details

NCT ID: NCT01546766
Date Last Changed: December 15, 2014

Overview

Research Study Summary

A clinical research study for the treatment of Diabetes or Retinal Disorders

Research Study Title

Developing a Non-invasive Method and Device for Assessing the Degree of Midperipheral Retinal Ischemia in Diabetic Retinopathy.

Purpose

The basic objective of this project is to test a modification of existing technology for monitoring the responses of the pupil to light as a method for detecting regional losses of function of the retina. The "instrument" consists of a commercially available set of goggles that monitor the eye positions and pupils using infrared light and small cameras. The signals from the monitoring cameras are collected in a computer that records how their pupils have responded to each lighting condition. Because diabetics develop damage initially to certain parts of the retina before they have more serious damage, the ultimate goal of this research is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in order to identify those who may require medical attention and/or therapy for diabetic retinopathy.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
University of California, Los Angeles
Duration
101 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • All subjects: must be greater than 18 years of age and capable of understanding informed consent.

  • All subjects must be willing to tolerate the placement of a set of goggles on their face.

  • All subjects must have visual acuities of 20/60 or better in at least one eye.

  • Normal subjects must have a history of a normal eye examination within one year prior to participation in this study.

  • Normal subjects must have no history of ocular disease and no history of diabetes.

  • Diabetic subjects must be diagnosed with diabetes upon prior clinical examination.

  • Retinal Conditions subjects must be diagnosed with a retinal pathology, hereditary or acquired.

Exclusion Criteria:

  • Subjects with glaucoma and high myopia are specifically excluded.

  • Diabetic subjects may not have had laser (panretinal photocoagulation) in both eyes.

Site Locations (2)

Country State City Zip Facility and Contact
United States California Los Angeles 90095 Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLA
Michael B. Gorin, MD, PhD
310-794-5400
gorin@jsei.ucla.edu

Michael B. Gorin, MD, PhD
Principal Investigator

Maria Carolina Ortube, MD
Sub-Investigator

Steve Nusinowitz, PhD
Sub-Investigator
United States Pennsylvania Pittsburgh 15238 Neuro Kinetics Inc.
Alexander Kiderman, PhD
412-963-6649
akiderman@neuro-kinetics.com

Contact

Michael B. Gorin, MD, PhD
1 (310) 794-5400
E-mail:

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