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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694145
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : June 29, 2021
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

Study Description
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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.

Study Design
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Study Type : Observational
Actual Enrollment : 300 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
Actual Primary Completion Date : June 8, 2021
Actual Study Completion Date : June 8, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients accurately diagnosed with retinopathy [ Time Frame: 9/2021 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
  • Patients whose teleretinal screening exam images yield readable results

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
  • Patients whose teleretinal screening exam images do not yield readable results, as gradable images are needed for later comparison against ophthalmologist reads.
  • 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).
Contacts and Locations
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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


Locations
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United States, California
Los Angeles Department of Public Health
Los Angeles, California, United States, 90012
University of California - Los Angeles
Los Angeles, California, United States, 90024
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States, 90059
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
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Principal Investigator: Omolola Ogunyemi, PhD Charles Drew University of Medicine and Science
More Information
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Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT03694145    
Other Study ID Numbers: 1218589-3
R01LM012309 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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