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.

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.