NCT05836194

Brief Summary

This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
769

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

April 18, 2023

Last Update Submit

August 20, 2024

Conditions

Retinal DiseasesDiabetic RetinopathyDiabetes ComplicationsDiabetes MellitusScreening

Keywords

Diabetic RetinopathyUltra wide-field imagingFundus PhotographyScreening

Outcome Measures

Primary Outcomes (1)

  • The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison

    To compare nonmydriatic 2-fields fundus photographs with nonmydriatic ultra-wide field images for determining diabetic retinopathy(DR) severity. DR severity level agreement will be cross-tabulated, and Kappa value will be calculated.

    60 days

Secondary Outcomes (2)

  • Number of Ungradable Images within the 2-field fundus photography and Optomap imaging

    7 day

  • Number of predominantly peripheral lession(PPL) with Optomap imaging

    7 day

Eligibility Criteria

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

Patients (18 and older) with diabetes presenting at the outpatient clinic of the Department of Ophthalmology, Ningbo Eye Hospital, practice for examination of diabetic retinopathy.

You may qualify if:

  • Age 18 years or older.
  • Diagnosis of diabetes mellitus.

You may not qualify if:

  • Diseases involving the posterior pole other than DR, such as age-related macular degeneration，retinal vein occlusion.
  • History of panretinal laser photocoagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Retinal DiseasesDiabetic RetinopathyDiabetes ComplicationsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Xiaotian Liu, MD

    Ningbo Eye Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 1, 2023

Study Start

October 1, 2022

Primary Completion

September 30, 2023

Study Completion

June 30, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations

CN(1)