A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

Conditions
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Myopia

Intervention / Treatment
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* Device: Visual Acuity with a Hand-held Device Supported by Mobile App.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Ages =>7 y.o. Subjects that are minors (<18 years old) must have a parent or legal guardian. Binocular vision Willing and able to give informed consent and follow all study procedures and requirements Fluent in English Be treated for myopia with Ortho-K, day contacts, or night contacts 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: Lack physical dexterity to properly operate the EyeQue App on the smartphone Lack the ability to follow instruction Lack binocular vision Lack the ability to maintain both eyes open Had eye surgery within the last 12 months (including Lasik)

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hand-held Device Supported by Mobile Application<br>Insight device ETDRS measurement compared to a standard ETDRS chart | Device: Visual Acuity with a Hand-held Device Supported by Mobile App.<br>* The Insight will be compared to a standard ETDRS eyechart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, Ortho-k, vision