Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06934577

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

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
900 (estimated)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERStandard optometric examinationParticipants 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.
OTHERTechnology enhanced eye disease detection protocolParticipants 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.

Timeline

Start date
2025-12-04
Primary completion
2030-08-01
Completion
2030-08-01
First posted
2025-04-18
Last updated
2025-12-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06934577. Inclusion in this directory is not an endorsement.