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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2021-09-10

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.

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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.

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Hand-held Device Supported by Mobile Application

Insight device ETDRS measurement compared to a standard ETDRS chart

Group Type OTHER

Visual Acuity with a Hand-held Device Supported by Mobile App.

Intervention Type DEVICE

The Insight will be compared to a standard ETDRS eyechart

Interventions

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Visual Acuity with a Hand-held Device Supported by Mobile App.

The Insight will be compared to a standard ETDRS eyechart

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or Female
2. Ages =\>7 y.o.
3. Subjects that are minors (\<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English
7. Be treated for myopia with Ortho-K, day contacts, or night contacts

Exclusion Criteria

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
2. Has traveled outside the country within the last 4 weeks
3. Medications:

a. Taking medications that may affect ability to follow instructions.
4. 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.
5. Subjects that:

1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
2. Lack the ability to follow instruction
3. Lack binocular vision
4. Lack the ability to maintain both eyes open
5. Had eye surgery within the last 12 months (including Lasik)

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes