Clinical trial NCT03694145: Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
Official title: Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
name: Los Angeles County Department of Public Health
name: University of California, Los Angeles
First posted: 2018-10-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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).

Primary outcomes:
measure: Proportion of patients accurately diagnosed with retinopathy
timeFrame: 11/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Department of Public Health
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Omolola Ogunyemi, PhD
role: PRINCIPAL_INVESTIGATOR
References: