Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
significant eye pain
sudden decrease in vision within one week
binocular diplopia
cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Standard optometric examination
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Control, standard optometric examinationExperimental treatment 2 interventions
Group B: Intervention, technology enhanced eye disease detection protocolExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)
Time frame
Visit 1(day 1)2
Rate of glaucoma/suspected glaucoma
Time frame
Visit 1 (Day 1)3
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)4
Rate of diabetic retinopathy
Time frame
Visit 1(day 1)Secondary outcomes
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 weeks2
Rate of disease in second allocation
Rate of glaucoma/glaucoma suspect in second allocation
Time frame
6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov