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The Diabetic Retinopathy Screening, Prevention and Control Program

The Diabetic Retinopathy Screening, Prevention and Control Program

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04240652
Enrollment
500000
Registered
2020-01-27
Start date
2018-06-05
Completion date
2040-06-05
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetic retinopathythrough study completion, up to 20 yearsdiabetic retinopathy
Referable diabetic retinopathythrough study completion, up to 20 yearsReferable diabetic retinopathy
Vision threatening diabetic retinopathythrough study completion, up to 20 yearsVision threatening diabetic retinopathy
Diabetic macular edemathrough study completion, up to 20 yearsDiabetic macular edema

Secondary

MeasureTime frameDescription
Salt intakethrough study completion, up to 20 years
Vegetable and fruits intakethrough study completion, up to 20 years
Physical activitythrough study completion, up to 20 years
Blood pressures (mmHg)through study completion, up to 20 years
Lipids (mg/dl)through study completion, up to 20 years
Body mass index (BMI)through study completion, up to 20 yearsBody weight (kg) and height (m) will be combined to report BMI in kg/m\^2
Systolic blood pressurethrough study completion, up to 20 years
Diastolic blood pressurethrough study completion, up to 20 years
Visceral fat (cm^2)through study completion, up to 20 years
Cardiolvascular diseasesthrough study completion, up to 20 years
Postprandial glucose (mmol/L)through study completion, up to 20 years
Fasting serum C peptide (ug/L)through study completion, up to 20 years
Postprandial serum C peptide (ug/L)through study completion, up to 20 years
Fasting serum insuline (μIU/mL)through study completion, up to 20 years
Postprandial serum insuline (μIU/mL)through study completion, up to 20 years
Intimal medial thikness (mm)through study completion, up to 20 years
Pulse wave velocity (cm/s)through study completion, up to 20 years
Albumin-creatinine-ratio (mg/mmol)through study completion, up to 20 years
Fasting glucose (mmol/L)through study completion, up to 20 years
HbA1c (%)through study completion, up to 20 years
Smoking historythrough study completion, up to 20 years
Alcohol intakethrough study completion, up to 20 years

Countries

China

Contacts

Primary ContactGuang Ning, MD,PHD
guangning@medmail.com.cn8621-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026