Viewing Study NCT02579837



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Study NCT ID: NCT02579837
Status: COMPLETED
Last Update Posted: 2021-03-23
First Post: 2015-10-16

Brief Title: CLEAR SIGHT A Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
Sponsor: Western University Canada
Organization: Western University Canada

Study Overview

Official Title: CLEAR SIGHT A Randomized Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 ie 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
Detailed Description: In this study the investigators are addressing a significant and expanding care-gap question for patients with diabetes who are at risk for diabetic retinopathy DR DR is a major cause of impaired health-related quality of life in Ontarians through visual loss including blindness Because the prevalence of DM in Ontario is increasing the number of Ontarians over age 40 years with sight-threatening DR has been projected to increase by 60 by 2031 DR is also a major source of health care costs in 2007 the estimated health care system expenditure for vision loss from DR in Canada was 205 million

There are proven effective strategies to prevent and treat DR These strategies strongly depend upon regular screening in asymptomatic patients Thus the 2013 CDA practice guidelines recommended annual eye screening by experienced eye care professionals either in-person or through interpretation of dilated pupil retinal photographs and yet despite the benefit of screening adherence to the CDA guidelines is poor At least part of this is due to patient-centered barriers including the need for mydriasis time off of work wait times and transportation issues Recent studies indicate that non-mydriatic UWF retinal imaging minimizes these barriers and also accurately detects clinically important DR as compared to reference standard tests dilated pupil eye exam by an eye care professional or 7-field stereoscopic colour fundus photography

In this study the investigators primary goal is to confirm or refute the hypothesis that screening by non-mydriatic UWF imaging at the time diabetes patients are seen for their routinely scheduled diabetes clinic visit On-site Screening improves the rate of detection of clinically important DR as compared to Usual Screening by the CDA guidelines While the investigators are not testing the effect of screening by non-mydriatic UWF on visual outcomes confirmation of the investigators hypothesis has the potential to improve current screening strategies for DR in Ontario and with that an expectation that this will reduce vision-threatening diabetic eye disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None