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Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2

NCT06934577 · University of Michigan
In plain English

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Official title
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial
About this study
To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.
Eligibility criteria
Inclusion Criteria: • Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog Exclusion Criteria: * significant eye pain * sudden decrease in vision within one week * binocular diplopia * cognitive impairment * pregnancy * previously declined participation
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-12-04
Estimated completion: 2030-08
Last updated: 2025-12-15
Interventions
Other: Standard optometric examinationOther: Technology enhanced eye disease detection protocol
Primary outcomes
  • Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy) (Visit 1(day 1))
  • Rate of glaucoma/suspected glaucoma (Visit 1 (Day 1))
  • Rate of visually significant cataract (Visit 1(day 1))
Sponsor
University of Michigan · other
With: Centers for Disease Control and Prevention
Contacts & investigators
ContactSuzanne Winter, MS · contact · wsuzanne@med.umich.edu · 734-763-6967
InvestigatorPaula Anne Newman-Casey, MD · principal_investigator, University of Michigan
All locations (1)
Hamilton Optometry ClinicRecruiting
Flint, Michigan, United States
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2 · TrialPath