Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1 U01DP006826-01-00 | Other Identifier | Centers for Disease Control and Prevention | |
| 1U01DP006826-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, standard optometric examination | Experimental | Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease. |
|
| Intervention, technology enhanced eye disease detection protocol | Experimental | 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 (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard optometric examination | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology. | Visit 1(day 1) |
| Rate of diabetic retinopathy | Visit 1(day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Rate of disease in second allocation |
Not provided
Inclusion Criteria:
• Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Winter, MS | Contact | 734-763-6967 | wsuzanne@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paula Anne Newman-Casey, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Optometry Clinic | Recruiting | Flint | Michigan | 48505. | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Technology enhanced eye disease detection protocol | Other | 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. |
|
Rate of glaucoma/glaucoma suspect in second allocation |
| 6 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009798 | Ocular Hypertension |