Diabetic Retinopathy, Low Vision
Conditions
Brief summary
Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.
Detailed description
In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision. Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.
Interventions
DEVICEEye4
Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.
OTHERPlacebo
This is the patient's best corrected vision with or without glasses/contact lenses
Sponsors
Eyedaptic
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Best correct visual acuity in the better seeing eye between 20/60 and 20/800 * History of diabetic retinopathy
Exclusion criteria
* Unable to complete the visit * Unable to give a reliable measurement of vision * Unable to comfortably wear the glasses for at least 60 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity at distance | Day 1 | Visual acuity at distance using Snellen Visual Acuity Chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity at near | Day 1 | Visual acuity at near tested using Ridgevue Near Vision chart |
| Contrast sensitivity | Day 1 | Contrast sensitivity measured using the Ridgevue contrast sensitivity scale |
Countries
United States
Outcome results
None listed