Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03694145
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
National Library of Medicine (NLM)
Los Angeles County Department of Public Health
University of California, Los Angeles
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science

Brief Summary:
The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.

Condition or disease Intervention/treatment
Diabetic Retinopathy Diabetic Macular Edema Other: In-Person Eye Examination

Detailed Description:

This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center.

For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination.

The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diabetic patients w. risk of retinopathy
The 300-500 patients to be enrolled for the study are diabetic patients normally seen by the Los Angeles County Department of Health Services (LACDHS) Teleretinal Diabetic Retinopathy Screening Program and Reading Center. In addition to receiving their recommended LACDHS annual teleretinal screening, for the study, participants will receive an additional in-person eye examination.
Other: In-Person Eye Examination
Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.




Primary Outcome Measures :
  1. Proportion of patients accurately diagnosed with retinopathy [ Time Frame: 09/2019 ]
    Proportion of patients accurately diagnosed with retinopathy using machine learning versus proportion accurately diagnosed by teleretinal screening optometrists with in-person eye examinations by ophthalmologists used as a gold standard.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population comprises patients with Type I or Type II diabetes who are normally seen at LACDHS clinics and usually screened for diabetic retinopathy via teleretinal screening.
Criteria

Inclusion Criteria:

  • Patients diagnosed with Type I or Type II Diabetes,
  • Patients who are over the age of 18 years
  • Patients who have not previously been seen in the current year by the LACDHS Teleretinal Diabetic Retinopathy Screening Program and Reading Center

Exclusion Criteria:

  • Patients under the age of 18 years
  • Patients with gestational diabetes
  • Patients who have previously been seen in the current year by LACDHS's Teleretinal Diabetic Retinopathy Screening Program and Reading Center
  • Previously eligible patients who do not return for an in-person eye exam within 3 months of receiving a teleretinal screening (In order for the results of the teleretinal screening and in-person eye examinations to yield similar information, patients who do not return for their in-person eye exam within 3 months of their teleretinal screening will not be able to remain in the study. This is because significant eye changes not documented by the teleretinal screening may occur after a 3-month period).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694145


Contacts
Layout table for location contacts
Contact: Junko Nishitani, PhD 323-563-4966 junkonishitani@cdrewu.edu

Locations
Layout table for location information
United States, California
Los Angeles Department of Public Health Recruiting
Los Angeles, California, United States, 90012
Contact: Lauren Daskivich, MD       lpdaskivich@dhs.lacounty.gov   
Contact: David Hindman, PhD       dhindman@ph.lacounty.gov   
Principal Investigator: Lauren Daskivich, MD         
Sub-Investigator: David Hindman, PhD         
University of California - Los Angeles Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Ricky Taira, PhD       rtaira@ucla.edu   
Principal Investigator: Ricky Taira, PhD         
Charles R. Drew University of Medicine and Science Not yet recruiting
Los Angeles, California, United States, 90059
Contact: Omolola Ogunyemi, PhD       lolaogunyemi@cdrewu.edu   
Contact: Muhsinah Saleem, MA       muhsinahsaleem@cdrewu.edu   
Principal Investigator: Omolola Ogunyemi, PhD         
Sub-Investigator: Lauren Daskivich, MD         
Sub-Investigator: Ricky Taira, PhD         
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Library of Medicine (NLM)
Los Angeles County Department of Public Health
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Omolola Ogunyemi, PhD Charles Drew University of Medicine and Science

Layout table for additonal information
Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT03694145     History of Changes
Other Study ID Numbers: 1218589-3
R01LM012309 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases