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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
900
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.
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.
Hamilton Optometry Clinic
Flint, Michigan, United States
RECRUITINGRate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)
Time frame: Visit 1(day 1)
Rate of glaucoma/suspected glaucoma
Time frame: Visit 1 (Day 1)
Rate of visually significant cataract
Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology.
Time frame: Visit 1(day 1)
Rate of diabetic retinopathy
Time frame: Visit 1(day 1)
Visual Function
The Visual Function Questionnaire (VFQ-9) is a 9-item survey that measures vision related quality-of-life and is scored from 0-100, where 100 represents the best visual function and vision-related quality-of-life.
Time frame: 6 weeks
Rate of disease in second allocation
Rate of glaucoma/glaucoma suspect in second allocation
Time frame: 6 weeks
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