Diabetic Retinopathy
Conditions
Keywords
screening, diabetic retinopathy, artificial intelligence
Brief summary
This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.
Interventions
DIAGNOSTIC_TESTMobile retinography interpreted by artificial intelligence
All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDIA group, their photos will be analyzed by artificial intelligence.
DIAGNOSTIC_TESTMobile retinography interpreted by ophthalmologists
All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDOF group, their photos will be interpreted remotely by ophthalmologists.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
TelessaúdeRS / UFRGS
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The AID-DR trial is designed as a randomized, controlled, double-blinded, non-inferiority trial with two parallel groups and a primary endpoint of adequate referrals to specialized care. Randomization will be performed in a 1:1 ratio using variable block sizes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.
Exclusion criteria
* Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy). * Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of appropriate referrals to ophthalmologist | Through study completion, an average of 1 year | Appropriate referrals: asymptomatic patients with moderate to severe nonproliferative DR, proliferative DR, significant macular edema, and uninterpretable exams. This data will be obtained by reviewing the medical records of ophthalmological in-person consults of included patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients referred for laser sessions | Through study completion, an average of 1 year | Considering only patients referred for argon laser sessions aiming retinal photocoagulation for the treatment of diabetic retinopathy. This data will be obtained through access to the medical records of patients referred for specialized care. |
| Number of pharmacological intraocular treatment | Through study completion, an average of 1 year | Considering treatment with anti-VEGF drugs or intravitreal corticosteroids for the treatment of diabetic retinopathy and diabetic macular edema. This data will be obtained through access to the medical records of patients referred for specialized care. |
| Referral failure | After study completion, an average of 15 months | Screening with false negative result. This data will be obtained by an independent ophthalmologist review of all images of the not referred patients. |
Countries
Brazil
Contacts
Primary ContactBeatriz D Schaan, MD, PhD
Outcome results
None listed