NCT04732208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

January 26, 2021

Last Update Submit

August 30, 2022

Conditions

Diabetic Retinopathy

Keywords

artificial intelligencescreeningfundus camera

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of the AI in detecting any grade of diabetic retinopathy in those with established diabetes mellitus (DM)

    4 months

Secondary Outcomes (3)

  • To assess the positive predictive value, negative predictive value of AI in detecting any grade of DR

    4 months

  • To assess the sensitivity to identify sight-threatening diabetic retinopathy (STDR defined as severe NPDR or more severe disease and/or the presence of DME ie grades U, M1, R2 or R3)

    4 months

  • To compare the diagnostic ability of the AI in mydriatic and non-mydriatic eyes

    4 months

Study Arms (1)

Diabetic patients

Diagnostic Test: Colour fundus photography

Interventions

Colour fundus photographyDIAGNOSTIC_TEST

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

Also known as: Instillation of mydriatic eye drops
Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with established diabetes mellitus presenting to GPs clinic for routine clinical care

You may qualify if:

  • Age above 18 years who can provide an informed consent
  • Established cases of diabetes mellitus (DM) with or without established diabetic retinopathy
  • Subjects who have been dilated for an ophthalmic evaluation previously

You may not qualify if:

  • Patients with acute vision loss
  • Participants contraindicated for fundus imaging if hypersensitive to light or underwent recent photodynamic therapy or is photosensitive
  • Participants who have been treated for diabetic retinopathy (laser or intra-vitreal injections) in the past 3 months
  • Participants known to have other known retinal pathologies
  • Participants identified to be at risk of acute angle closure glaucoma from previous ophthalmic evaluation (anterior chamber depth, gonioscopy to look at angles and IOP)
  • Participants with known allergy to 1% tropicamide solution
  • Currently participating in another investigational eye study and/or actively receiving investigational product for DR or diabetic macula edema.
  • Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status- glycemic control, blood pressure etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Edward Jude

Manchester, OL6 9RW, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

April 20, 2022

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)