Diabetes Mellitus
Conditions
Brief summary
The long-term goal for this study is to improve compliance of screening for diabetic retinopathy among subjects with diabetes. Researchers are also doing this research to determine the ability of appropriately trained family physicians to screen for and identify Diabetic Retinopathy using a retinal camera in addition to determining an overall patient perspective of the convenience and cost-effectiveness of retinal imaging within a primary care setting.
Interventions
OTHERScreening eye exam using Optos technology
Retinal imaging using Optos technology to identify Diabetic Retinopathy
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient ≥ 18 years of age * Diabetes Mellitus Type I or II * Patient is willing and able to provide informed written consent
Exclusion criteria
• Known Diabetic Retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist | 6 months. | Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist. These photographs are obtained using retinal imaging and after the initial read by the family physicians trained to interpret the images, the images will be reviewed by the retinal specialist to determine if the interpreted results are accurate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging. | 6 months | Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging using OPTOS when compared with the traditional dilated eye exam.The current screening rate is around 55%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 6 months | Percentage change in patient satisfaction and how much are patients willing to pay out of pocket to screen for Diabetic Retinopathy using retinal imaging. Each patient will be surveyed and these questions will help determine patient satisfaction and their willingness to pay for this versus usual care. We will ask the following questions: 1. Did you find the Retinal Imaging an easy/efficient way of screening for eye disease as a result of having diabetes? Yes/No 2. If you had to pay for this out-of-pocket what is the maximum amount you would be willing to pay? 1. $25 2. $50 3. $75 4. $100 5. \>$100 This will help us determine the patient's level of satisfaction and their willingness to pay out of pocket for the service. |
Countries
United States
Outcome results
None listed