Design of a Pragmatic Randomized Controlled Trial for Comparing the Michigan Screening and Intervention for Glaucoma and Eye Health and Telemedicine Protocol with Usual Care for Disease Detection

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Purpose: To detail the methodology for the Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine Program Pragmatic Trial (MI-SIGHT 2) a follow-up to the original MI-SIGHT program that showed feasibility under ideal conditions and efficacy without a comparator. Patients and Methods: A pragmatic randomized controlled trial will compare rate of eye disease detected using the technology-based approach of the MI-SIGHT 2 program (intervention) vs standard optometric exam (control) in a Federally Qualified Health Center (FQHC) (n=900). Inclusion criteria are age ≥ 18 years and no acute eye symptoms. Exclusion criteria are pregnancy or cognitive impairment. The MI-SIGHT 2 intervention leverages technologies including autorefraction, pachymetry, optical coherence tomography, and external and fundus photography, in addition to care navigation support to access low-cost eyeglasses through an on-line retailer and support attendance at recommended follow-up. The primary outcome is detected eye disease as measured by an in-person optometrist exam (control) or by optometrist interpretation of the MI-SIGHT 2 technology-based protocol (intervention). The eye diseases targeted for detection include glaucoma/suspected glaucoma, visually significant cataract, and diabetic retinopathy. The secondary outcome is vision-related quality of life ascertained by survey six weeks after the initial study visit. The exploratory outcomes are program satisfaction and recommended follow-up completion. A cross-over design also will investigate within-person inconsistencies in diagnosis between arms by having participants undergo both screening approaches in randomized order. We will also determine accuracy of diagnoses by each protocol compared to a gold-standard diagnosis determined and adjudicated by glaucoma specialists. Two glaucoma specialist physicians will review all technology-based exams to assess the presence of eye diseases; a third glaucoma specialist physician will adjudicate when there is disagreement. Conclusion: This pragmatic trial will generate evidence to inform best practices for glaucoma and eye disease screening at community health centers.

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