Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
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|ClinicalTrials.gov Identifier: NCT03694145|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment|
|Diabetic Retinopathy Diabetic Macular Edema||Other: In-Person Eye Examination|
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 Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
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.
- Proportion of patients accurately diagnosed with retinopathy [ Time Frame: 11/2022 ]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.
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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|
- 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
- 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).
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
|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|
|Principal Investigator:||Omolola Ogunyemi, PhD||Charles Drew University of Medicine and Science|
|Responsible Party:||Charles Drew University of Medicine and Science|
|Other Study ID Numbers:||
R01LM012309 ( U.S. NIH Grant/Contract )
|First Posted:||October 3, 2018 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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