search
Back to results

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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Acuity with a Hand-held Device Supported by Mobile App.
Sponsored by
EyeQue Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Myopia focused on measuring myopia, Ortho-k, vision

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Eye Boutique Optometry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hand-held Device Supported by Mobile Application

Arm Description

Insight device ETDRS measurement compared to a standard ETDRS chart

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 29, 2020
Last Updated
August 19, 2022
Sponsor
EyeQue Corp.
Collaborators
Eye Boutique Optometry
search

1. Study Identification

Unique Protocol Identification Number
NCT04693260
Brief Title
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Official Title
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeQue Corp.
Collaborators
Eye Boutique Optometry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, Ortho-k, vision

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand-held Device Supported by Mobile Application
Arm Type
Other
Arm Description
Insight device ETDRS measurement compared to a standard ETDRS chart
Intervention Type
Device
Intervention Name(s)
Visual Acuity with a Hand-held Device Supported by Mobile App.
Intervention Description
The Insight will be compared to a standard ETDRS eyechart
Primary Outcome Measure Information:
Title
Departure from scheduled follow-up visits with clinical confirmation
Description
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.
Time Frame
Approximately 21 Weeks
Secondary Outcome Measure Information:
Title
Measure rapidly changing visual acuity
Description
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.
Time Frame
Approximately 21 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Eye Boutique Optometry
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs