NCT01546766

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

8.5 years

First QC Date

March 1, 2012

Last Update Submit

November 3, 2023

Conditions

DiabetesRetinal Disorders

Keywords

DiabetesPupillary responseRetinal disordersMidperipheral ischemiaFundus photographyOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Pupillary response

    We will analyze the following three components of the pupillary response: latency, constriction velocity and amplitude. The measurements will be taken after initiation of the light stimulus. These functions will be determined for each eye of each subject using both the central and annular stimuli. Each set of experimental conditions will yield a unique relative luminance ratio that can be used to compare the relative functional integrity of the peripheral retina with respect to the central macula.

    3 months

Secondary Outcomes (1)

  • Pupillary response.

    1 year

Study Arms (3)

Subjects with diabetes

(Subjects that have been diagnosed with diabetes).

Device: Pupillometry testing.

Control volunteers

(Subjects with no history of ocular problems).

Device: Pupillometry testing.

Subjects with retinal conditions

(Subjects with a history of retinal disorders except diabetes).

Device: Pupillometry testing.

Interventions

Pupillometry testing.DEVICE
Control volunteersSubjects with diabetesSubjects with retinal conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

145 normal adults 270 adults with diabetic retinopathy 50 adults with retinal conditions

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with glaucoma and high myopia are specifically excluded.
  • Diabetic subjects may not have had laser (panretinal photocoagulation) in both eyes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Neuro Kinetics Inc.

Pittsburgh, Pennsylvania, 15238, United States

Location

Related Publications (1)

  • Ortube MC, Kiderman A, Eydelman Y, Yu F, Aguilar N, Nusinowitz S, Gorin MB. Comparative regional pupillography as a noninvasive biosensor screening method for diabetic retinopathy. Invest Ophthalmol Vis Sci. 2013 Jan 2;54(1):9-18. doi: 10.1167/iovs.12-10241.

    PMID: 23154459RESULT

MeSH Terms

Conditions

Diabetes MellitusRetinal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesEye Diseases

Study Officials

  • Michael B. Gorin, MD, PhD

    Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLA

    PRINCIPAL INVESTIGATOR

  • Alexander Kiderman, PhD

    Neuro Kinetics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

February 1, 2007

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

US(2)