Hamilton Optometry Clinic
Flint, Michigan, 48505., United States
Location status: Recruiting
Location contact
David Bush, OD
CONTACT
Paula Anne Newman-Casey, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06934577
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Flint, Michigan, 48505., United States
Location status: Recruiting
David Bush, OD
CONTACT
Paula Anne Newman-Casey, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Visit 1(day 1)
Time frame: Visit 1 (Day 1)
Time frame: Visit 1(day 1)
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)
Time frame: 6 weeks
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 glaucoma/glaucoma suspect in second allocation
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial
Acronym: SIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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