The Diabetic Retinopathy Screening, Prevention & Control Program

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04240652
Study type	Observational [Patient Registry]
Source	Shanghai Jiao Tong University School of Medicine
Contact	Guang Ning, MD,PHD
Phone	8621-64370045
Email	guangning@medmail.com.cn
Status	Recruiting
Phase
Start date	June 5, 2018
Completion date	June 5, 2040

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Diabetic Retinopathy Screening, Prevention and Control Program

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms