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

NCT02579837 | Completed

• 1 other identifier: 106583
• Study Type: interventional
• Target: 742
• Locations: 1 country
• Sites: 1

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, 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

Diabetes Mellitus; Diabetic Retinopathy

Keywords

screening

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Actionable Eye Disease (AED)

  Usual Screening Group: AED will be based upon DR grading and the disposition recommendation as that information is provided on the exam report from the participant's usual eye care professional. Any one of the following will be considered indicative of AED if noted on the report: a) moderate or severe non-proliferative DR; b) any proliferative DR; c) clinically significant macular edema (CSME); d) referral to an ophthalmologist; e) recommendation for re-examination in \<12 months. On-Site Screening Group: AED will be based on interpretation of non-mydriatic UWF images by a retinal specialist where AED will require at least 1 finding of: DR (intra-retinal microvascular abnormalities or venous beading \>/= 2 quadrants, neovascularization elsewhere, neovascularization of the disc, vitreous hemorrhage) or diabetic maculopathy (microaneurysms, retinal hemorrhages or exudates within 1 disc diameter of the fovea)

  within 12 months of randomization

Secondary Outcomes (2)

• Screening Adherence (rate of screening via primary assigned screening method)

  within 12 months of randomization

• Proportion of participants with Diabetic Maculopathy (DME)

  within 12 months of randomization

Study Arms (2)

Usual Screening

NO INTERVENTION

Participants randomized to the Usual Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care).

On-Site Screening

EXPERIMENTAL

Participants randomized to the On-Site Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care). However, they will also undergo non-mydriatic ultra-widefield (UWF) retinal imaging (both 100 and 200 degrees) using the Optos 200Tx UWF retinal imaging device in the Ophthalmology Department on the same day as their Diabetes Clinic visit. Half of this group will by random allocation undergo optical coherence tomography (OCT) using the Zeiss Cirrus OCT, which may or may not be done on the same day (for practical reasons regarding availability of OCT at the hospital).

Device: Optos 200Tx; Device: Zeiss Cirrus

Interventions

Optos 200Tx DEVICE

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

On-Site Screening

Zeiss Cirrus DEVICE

optical coherence tomographer (OCT)

On-Site Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known diagnosis of Type 1 diabetes for \>/= 5 years or Type 2 diabetes of any duration
• At least 12 months since the last screening for diabetic eye disease by an eye care professional as this is based on patient self-report. Subsequent confirmation of the date of the last eye examination will be obtained via communication with the patient's eye care professional. Patients who indicate by self-report that it has been more than a year since screening, but in whom it is subsequently confirmed that their last screen occurred \<12 months prior to entry, will be randomized but will not be included in the primary analysis comparing On-Site to Usual Screening.
• Provision of informed consent

You may not qualify if:

• Under active followup by an ophthalmologist for DM-related eye disease. Active followup requires that, at recruitment, the patient is scheduled for a future ophthalmologist appointment for any reason.
• Inability to provide informed consent.
• Any other condition or circumstance which in the judgment of the investigator makes it unlikely that the patient can adhere to the study protocol. This includes co-morbidities for which expected life-expectancy is less than a year.

Sponsors & Collaborators

• Western University, Canada: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• Liu SL, Mahon LW, Klar NS, Schulz DC, Gonder JR, Hramiak IM, Mahon JL. A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial. BMJ Open. 2017 Aug 3;7(8):e015382. doi: 10.1136/bmjopen-2016-015382.

  PMID: 28775182 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Selina L Liu, MD MSc FRCPC

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Endocrinology & Metabolism, Department of Medicine, Schulich School of Medicine & Dentistry

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 20, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)