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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| TelessaúdeRS / UFRGS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDIA group | Experimental | The proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. |
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| RDOF group | Active Comparator | The proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile retinography interpreted by artificial intelligence | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of appropriate referrals to ophthalmologist | 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients referred for laser sessions | 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. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz D Schaan, MD, PhD | Contact | +55 51 3359-8127 | bschaan@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Beatriz D Schaan, MD, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36864478 | Background | Chagas TA, Dos Reis MA, Leivas G, Santos LP, Gossenheimer AN, Melo GB, Malerbi FK, Schaan BD. Prevalence of diabetic retinopathy in Brazil: a systematic review with meta-analysis. Diabetol Metab Syndr. 2023 Mar 2;15(1):34. doi: 10.1186/s13098-023-01003-2. | |
| 37328386 | Background | Schneiders J, Telo GH, Lavinsky D, Dos Reis MA, Correa BG, Schaan BD. Organizational intervention to improve access to retinopathy screening for patients with diabetes mellitus: health care service improvement project in a tertiary public hospital. Prim Care Diabetes. 2023 Aug;17(4):354-358. doi: 10.1016/j.pcd.2023.05.007. Epub 2023 Jun 14. |
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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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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.
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| Mobile retinography interpreted by ophthalmologists | Diagnostic Test | 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. |
|
| Number of pharmacological intraocular treatment |
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. |
| Through study completion, an average of 1 year |
| Referral failure | Screening with false negative result. This data will be obtained by an independent ophthalmologist review of all images of the not referred patients. | After study completion, an average of 15 months |
| 39210394 | Background | Dos Reis MA, Kunas CA, da Silva Araujo T, Schneiders J, de Azevedo PB, Nakayama LF, Rados DRV, Umpierre RN, Berwanger O, Lavinsky D, Malerbi FK, Navaux POA, Schaan BD. Advancing healthcare with artificial intelligence: diagnostic accuracy of machine learning algorithm in diagnosis of diabetic retinopathy in the Brazilian population. Diabetol Metab Syndr. 2024 Aug 29;16(1):209. doi: 10.1186/s13098-024-01447-0. |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |