Effectiveness of non-mydriatic ultra-widefield retinal imaging to screen for diabetic eye disease: a randomized controlled trial (Clearsight)

Abstract

<p> </p> <p>Objective</p> <p>Suboptimal diabetic eye disease screening is a major cause of preventable vision loss. Screening barriers include mydriasis and need for dedicated screening appointments. The Clearsight trial assessed whether non-mydriatic ultra-widefield (NM UWF) screening on the day of a diabetes clinic visit improved detection of clinically important eye disease vs usual screening.</p> <p>Research Design and Methods </p> <p>This single-center, randomized, parallel-group controlled trial was conducted at St. Joseph’s Health Care, London, Canada. Adults with diabetes due for screening were randomized to same-day On-Site Screening (NM UWF imaging) on the day of a scheduled diabetes clinic visit or Usual Screening (encouraged to arrange optometrist screening). The primary outcome was detection of actionable eye disease (AED) defined as need for ophthalmology referral or increased ocular surveillance. The primary analysis (modified intention-to-screen) compared the proportions of AED between groups within one year of enrollment. </p> <p>Results </p> <p>Of 740 participants randomized between March 7, 2016 and April 17, 2019, 335 On-Site Screening and 323 Usual Screening participants met criteria for the primary analysis. More AED was detected in the On-Site Screening than Usual Screening groups (50/335 [14.9%] vs 22/323 [6.8%]; adjusted odds ratio 2.51 [95% CI 1.49–4.36]). The number-needed-to-screen by On-Site Screening to detect one additional patient with AED was 13 [95% CI 8–29].</p> <p>Conclusions </p> <p>Same-day On-Site Screening by NM UWF imaging increased detection of clinically important diabetic eye disease vs Usual Screening. Integration of NM UWF imaging into routine diabetes clinic visits improved screening adherence and has the potential to prevent vision loss.</p>