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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye4 | Experimental | This is the arm with the Eyedaptic Device |
|
| Baseline | Placebo Comparator | This is the placebo arm with the best correction the subject has |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye4 | Device | Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity at distance | Visual acuity at distance using Snellen Visual Acuity Chart | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity at near | Visual acuity at near tested using Ridgevue Near Vision chart | Day 1 |
| Contrast sensitivity | Contrast sensitivity measured using the Ridgevue contrast sensitivity scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitul Mehta, MD | Eyedaptic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eyedaptic | Laguna Hills | California | 92653 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Placebo | Other | This is the patient's best corrected vision with or without glasses/contact lenses |
|
| Day 1 |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |