Real-world Diagnostic Effectiveness of Artificial Intelligence Algorithm in Diabetic Retinopathy Screening

NCT03911323 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-04-11

No results posted yet for this study

Summary

Recently, artificial intelligence algorithm has made great progress in the prediction of diabetic retinopathy based on fundus images,showing very high sensitivity and specificity. However,the real-world diagnosis effectiveness of deep learning model is still unclear.

This study is designed to evaluate the clinical efficacy of such an algorithm in detecting referable diabetic retinopathy.

Conditions

Interventions

OTHER

diabetic retinopathy

Patients with diabetes enrolled will undergo nonmydriatic fundus imaging and seven-field stereoscopic photography. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the AI algorithm will be compared to the diagnosis of seven-field stereoscopic photography by ophthalmologist. Sensitivity and specificity will be calculated to evaluate the performance of AI algorithm.

Sponsors & Collaborators

  • Shenzhen Second People's Hospital

    lead OTHER

Principal Investigators

  • Lisha Mou, PhD · Shenzhen Second People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911323 on ClinicalTrials.gov