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| ID | Type | Description | Link |
|---|---|---|---|
| R01LM012309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Library of Medicine (NLM) | NIH |
| Los Angeles County Department of Public Health | OTHER_GOV |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person Eye Examination | Other | Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients accurately diagnosed with retinopathy | 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. | 11/2022 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Omolola Ogunyemi, PhD | Charles Drew University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Department of Public Health | Los Angeles | California | 90012 | United States | ||
| University of California - Los Angeles |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Los Angeles |
| California |
| 90024 |
| United States |
| Charles R. Drew University of Medicine and Science | Los Angeles | California | 90059 | United States |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |