CLEAR SIGHT: A Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
Diabetes Mellitus, Diabetic Retinopathy
About this trial
This is an interventional screening trial for Diabetes Mellitus focused on measuring screening
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- St. Joseph's Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Usual Screening
On-Site Screening
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).
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).