Automated Screening of Diabetic Retinopathy Using a Smartphone-based Camera

NCT04732208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 410

Last updated 2022-09-02

No results posted yet for this study

Summary

The prevalence of diabetic retinopathy (DR) in the UK is on the rise. Within 20 years of diabetes diagnosis, nearly all people with type 1 and almost two thirds of people with type 2 diabetes (60%) have some degree of DR. NHS guidelines mandate annual DR screening in all patients aged 12 and above to prevent complications of DR. Screening for DR in England involves labour-intensive manual grading of retinal images through the teleophthalmology platform. Automated retinal image analysis systems with the use of artificial intelligence (AI) may offer an alternative to manual grading.

The purpose of this study is to evaluate the performance of a portable, hand-held fundus camera with integrated artificial intelligence for diabetic retinopathy screening by comparing it against the current standard i.e diagnosis provided by trained human graders evaluating the standard photographs/ophthalmologists.

Conditions

Interventions

DIAGNOSTIC_TEST

Colour fundus photography

Fundus images will be captured before and after administration of mydriatic agent

Sponsors & Collaborators

  • Tameside General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-08-24
Completion
2022-08-24

Countries

  • United Kingdom

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 NCT04732208 on ClinicalTrials.gov