Eye Diseases, Glaucoma, Visual Impairment
Conditions
Keywords
Eye disease screening, Glaucoma detection
Brief 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.
Interventions
OTHERStandard 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.
OTHERTechnology 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.
Sponsors
Centers for Disease Control and Prevention
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician assessing the main outcome measure will be masked. A second statistician, not masked to treatment allocation, will tabulate weekly reports of adverse events by treatment group for review by the medical monitor.
Intervention model description
Participants meeting inclusion criteria who are 18 years of age or older will be randomized to either 1) control group: standard optometric examination or 2) intervention group: technology-enhanced eye disease screening protocol. Randomization will be stratified by disease risk in two strata: 1) those with and without diabetes, and 2) those \< age 40 and those ≥ age 40. After stratification, participants will be block randomized to the control or intervention arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology. |
| Rate of diabetic retinopathy | Visit 1(day 1) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Function | 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. |
| Rate of disease in second allocation | 6 weeks | Rate of glaucoma/glaucoma suspect in second allocation |
Countries
United States
Contacts
Primary ContactSuzanne Winter, MS
Outcome results
None listed