The Diabetic Retinopathy Screening, Prevention and Control Program
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Diabetic Retinopathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The greatest harm of diabetes is various acute and chronic complications, especially diabetic retinopathy(DR), leading to extremely high rates of disability and blindness. Early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate. To change this situation, deep learning(DL), a form of artificial intelligence (AI), might be a potential effective method to solve this dilemma.
Подробное описание
The greatest harm of diabetes is various acute and chronic complications, especially DR, leading to extremely high rates of disability and blindness. However, if the fundus examination is carried out regularly in the early stages of onset, the risk of blindness can be significantly reduced. Therefore, early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate.
The Diabetic Retinopathy Screening and Prevention Program is a branch project of MMC. Its purpose is to carry out an efficient workflow for early detecting, timely managing of DR, and to establish a referral system for implementing treatment and the long-term follow-up of DR by means of DL. First, In order to improve its sensitivity and specificity, more participants are involved in other medical institutes besides MMCs, then we can effectively explore the prevalance of DR in China and helps to early screening, prevention, treatment and referal process of DR. Secend, we collect participants' serum, plasma,DNA, several medical stastistics and life styles to explore genetics, new biomarkers, risk factors of DR.
Objective:
1. To validate the methodology and feasibility of DR screening using a DL based automated DR grading system in clinical practice. 2. To explore the prevalence of DR and subgroup identification, and fundus images analysis, etc. 3. To explore the genetics, new biomarkers, risk factors of DR. 4. To explore the methods of early screening, prevention, treatment and referal process of DR.
Первичные конечные точки
- Diabetic retinopathy [Срок оценки: through study completion, up to 20 years]
- Referable diabetic retinopathy [Срок оценки: through study completion, up to 20 years]
- Vision threatening diabetic retinopathy [Срок оценки: through study completion, up to 20 years]
- Diabetic macular edema [Срок оценки: through study completion, up to 20 years]
Вторичные конечные точки (12)
- HbA1c (%) [Срок оценки: through study completion, up to 20 years]
- Smoking history [Срок оценки: through study completion, up to 20 years]
- Alcohol intake [Срок оценки: through study completion, up to 20 years]
- Salt intake [Срок оценки: through study completion, up to 20 years]
- Vegetable and fruits intake [Срок оценки: through study completion, up to 20 years]
- Physical activity [Срок оценки: through study completion, up to 20 years]
- Blood pressures (mmHg) [Срок оценки: through study completion, up to 20 years]
- Lipids (mg/dl) [Срок оценки: through study completion, up to 20 years]
- Cardiolvascular diseases [Срок оценки: through study completion, up to 20 years]
- Body mass index (BMI) [Срок оценки: through study completion, up to 20 years]
- Systolic blood pressure [Срок оценки: through study completion, up to 20 years]
- Diastolic blood pressure [Срок оценки: through study completion, up to 20 years]
Критерии участия
Критерии включения
- Meet the diagnostic criteria for type 2 diabetes according to the World Health Organization (WHO) in 1999; Type 1 diabetes, single gene mutation diabetes, secondary diabetes caused by pancreatic damage, Cushing's syndrome, thyroid dysfunction, or acromegaly;
- Subjects from other medical institutes are diabetes, non-diabetic patients and healthy participants who are invited to participate in the study.
Критерии исключения
- Those who have a history of drug abuse;
- Sexually transmitted diseases such as AIDS and syphilis, and infectious diseases such as viral hepatitis and tuberculosis which are at active phase;
- Any condition that the investigator think that the subject is not suitable for participating in the study.
For detailed In-/Ex-clusion criteria please see the study protocol.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 2 центра
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine — Шанхай
- Shanghai Jiao-Tong University School of Medicine — Шанхай
Публикации
- Zhang Y, Shi J, Peng Y, Zhao Z, Zheng Q, Wang Z, Liu K, Jiao S, Qiu K, Zhou Z, Yan L, Zhao D, Jiang H, Dai Y, Su B, Gu P, Su H, Wan Q, Peng Y, Liu J, Hu L, Ke T, Chen L, Xu F, Dong Q, Terzopoulos D, Ning G, Xu X, Ding X, Wang W. Artificial intelligence-enabled screening for diabetic retinopathy: a real-world, multicenter and prospective study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001596. doi PMID 33087340
Идентификаторы
NCT: NCT04240652 · Ruijin-20191231