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| Name | Class |
|---|---|
| Eye Boutique Optometry | UNKNOWN |
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The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-held Device Supported by Mobile Application | Other | Insight device ETDRS measurement compared to a standard ETDRS chart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity with a Hand-held Device Supported by Mobile App. | Device | The Insight will be compared to a standard ETDRS eyechart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Departure from scheduled follow-up visits with clinical confirmation | Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted. | Approximately 21 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure rapidly changing visual acuity | Ability to track and measure visual acuity with the EyeQue Insight in patients with rapidly changing visual acuity during the first month of Ortho-K introduction. | Approximately 21 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
Has traveled outside the country within the last 4 weeks
Medications:
a. Taking medications that may affect ability to follow instructions.
Eye Disease:
a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.
Subjects that:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Boutique Optometry | Santa Clara | California | 95051 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D009799 | Ocular Physiological Phenomena |