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CLEAR SIGHT: A Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease

NCT02579837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 742

Last updated 2021-03-23

No results posted yet for this study

Summary

Diabetic eye disease causes major vision loss in many Canadians and is costly. There are effective preventions and treatments for diabetic eye disease but they strongly depend upon regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA) guidelines recommend annual screening by eye care professionals, either in-person or through interpretation of dilated pupil retinal photographs.

Despite the benefits of screening, adherence to these guidelines is poor. Reasons include patient barriers, i.e. need for eye drops, time off work, wait times, and transportation issues. An option to minimize these barriers is to screen using a camera called non-mydriatic ultra-widefield (UWF) retinal imaging. This can be quickly done without eye drops on the same day as patients' regularly scheduled diabetes clinic visits.

In this study, the investigators will compare the UWF camera to the usual screening approach recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye screening to either be screened using the UWF camera on the day of their diabetes clinic visit or be screened by their usual eye care professional. The investigators' prediction is that same-day screening with UWF imaging will find more patients with diabetic eye disease who need treatment compared to usual screening.

Conditions

Interventions

DEVICE

Optos 200Tx

non-mydriatic ultra-widefield (UWF) retinal imaging device

DEVICE

Zeiss Cirrus

optical coherence tomographer (OCT)

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Selina L Liu, MD MSc FRCPC · Western University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02579837 on ClinicalTrials.gov