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
Autor: | Jeffrey L. Mahon, Lewis W Mahon, David C. Schulz, Selina L. Liu, Neil Klar, Irene Hramiak, John R. Gonder |
---|---|
Rok vydání: | 2017 |
Předmět: |
Adult
Male Mydriatics medicine.medical_specialty Pediatrics Adolescent Referral Eye disease Alternative medicine Retina Diabetic Eye Disease 03 medical and health sciences 0302 clinical medicine Diabetes mellitus Diabetes Mellitus Protocol medicine Humans Mass Screening Outpatient clinic 030212 general & internal medicine Aged Protocol (science) Diabetic Retinopathy business.industry screening General Medicine Middle Aged Institutional review board medicine.disease diabetic eye disease Diabetes and Endocrinology non-mydriatic ultra-wide field imaging Research Design 030221 ophthalmology & optometry Physical therapy Female business |
Zdroj: | BMJ Open |
ISSN: | 2044-6055 |
Popis: | IntroductionSuboptimal screening for diabetic eye disease is a major cause of preventable vision loss. Screening barriers include mydriasis and the extra time patients need to attend dedicated eye screening appointments. In the Clearsight trial, we are testing whether screening by non-mydriatic ultra-wide field (NM UWF) imaging on the day patients attend their diabetes outpatient clinic visit improves detection of clinically important eye disease compared with usual screening.Methods and analysisPatients with diabetes due for a screening eye exam by the 2013 Canadian Diabetes Association (CDA) practice guidelines are being randomised to on-site screening by NM UWF imaging on the day of their clinic visit or to usual screening where, per CDA guidelines, they are encouraged to arrange an exam by an optometrist. The primary outcome is actionable eye disease (AED) based on a need for referral to ophthalmology and/or increased ocular surveillance. The primary analysis will use an intention-to-screen approach that compares the proportions of detected AED between on-site and usual screening groups under a superiority hypothesis in favour of on-site screening. With 740 randomised participants, the study will have 80% power to detect ≥5% absolute increase in the AED rate among on-site screening versus usual screening participants. This difference translates into a number-needed-to-screen by on-site screening of 20 to detect 1 additional person with AED.Ethics and disseminationThe protocol was approved by the institutional review board of Western University. The findings of the trial will be disseminated directly to participants and through peer-reviewed publications and conference presentations.Trial registration numberClinicalTrials.GovNCT02579837(registered 16 October 2015).Protocol issue date18 November 2015. |
Databáze: | OpenAIRE |
Externí odkaz: |