Recruiting
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2
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.
ClinicalTrials.gov IDNCT06934577
PhaseNA
Enrollment900
SponsorUniversity of Michigan
Age18 Years
SexALL
Conditions studied
Eye Diseases, Visual Impairment, Glaucoma
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.
Interventions
- Other: Standard optometric examination — 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.
- Other: 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 (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.
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))
- Rate of diabetic retinopathy (Visit 1(day 1))
Eligibility information
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 locations
- Hamilton Optometry Clinic, Flint, Michigan 48505. United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.