Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care

Официальное название

Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes

Обзор

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.

Вмешательства

• Диагностический тест Mobile 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.
• Диагностический тест Mobile 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.

Первичные конечные точки

• Number of appropriate referrals to ophthalmologist [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (3)

• Number of patients referred for laser sessions [Срок оценки: Through study completion, an average of 1 year]
• Number of pharmacological intraocular treatment [Срок оценки: Through study completion, an average of 1 year]
• Referral failure [Срок оценки: After study completion, an average of 15 months]

Критерии участия

Критерии включения

• Adults (> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.

Критерии исключения

• Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).
• Life expectancy less than 6 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Скрининг

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre — Porto Alegre

Публикации

• 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. PMID 36864478
• 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. PMID 37328386
• 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- PMID 39210394

Идентификаторы

NCT: NCT07236879 · 2024-0238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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