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

Part of paid clinical trials in Flint, Michigan.

Sponsor
University of Michigan
Study ID
NCT06934577
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard optometric examination — OTHER
    Participants will see the optometrist at the Federally Qualified Health Center. The guidelines define usual care as: an in-person comprehensive eye examination with assessment of patient history, visual acuity, pupil examination, ocular motility and alignment, intraocular pressure, and biomicroscopy with additional tests, as appropriate. A glasses prescription will be given to the participant if needed. Participants will complete surveys at baseline before their eye exam and 6 weeks after the eye exam.
  • Technology enhanced eye disease detection protocol — OTHER
    Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (no disease detected) or an in-depth appointment with the optometrist (disease detected). During the first visit, participants receive care navigation support to purchase low-cost glasses from an on-line retailer. When participants return for the optometrist exam, glasses will be fit. Participants will receive care navigation support to attend any recommended specialty follow-up appointments.

Study Details

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.

Key Dates

Start date
Dec 4, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Control, standard optometric examination
    Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease.
  • Experimental: Intervention, technology enhanced eye disease detection protocol
    Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected).

Primary Outcome Measure

Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy) [ Time Frame: Visit 1(day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hamilton Optometry ClinicFlintMichigan48505.
David Bush, OD
[email protected]
810-406-4246
Paula Anne Newman-Casey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Flint, MI

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Hamilton Optometry Clinic· Flint, MI

Related Studies