Clincosm LogoSign in Get a demo

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

Sponsor
EyeQue Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT04693260
Collaborator
Eye Boutique Optometry (Other)
32
Enrollment
1
Location
1
Arm
14.3
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Visual Acuity with a Hand-held Device Supported by Mobile App.
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Actual Study Start Date :
Jul 3, 2020
Actual Primary Completion Date :
Sep 10, 2021
Actual Study Completion Date :
Sep 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Hand-held Device Supported by Mobile Application

Insight device ETDRS measurement compared to a standard ETDRS chart

Device: Visual Acuity with a Hand-held Device Supported by Mobile App.
The Insight will be compared to a standard ETDRS eyechart

Outcome Measures

Primary Outcome Measures

  1. Departure from scheduled follow-up visits with clinical confirmation [Approximately 21 Weeks]

    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

  1. Measure rapidly changing visual acuity [Approximately 21 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

  1. Taking medications that may affect ability to follow instructions.
  1. Eye Disease:
  1. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.

  1. Subjects that:

  2. Lack physical dexterity to properly operate the EyeQue App on the smartphone

  3. Lack the ability to follow instruction

  4. Lack binocular vision

  5. Lack the ability to maintain both eyes open

  6. Had eye surgery within the last 12 months (including Lasik)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Boutique Optometry Santa Clara California United States 95051

Sponsors and Collaborators

  • EyeQue Corp.
  • Eye Boutique Optometry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyeQue Corp.
ClinicalTrials.gov Identifier:
NCT04693260
Other Study ID Numbers:
  • EYEQUE - 007
First Posted:
Jan 5, 2021
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by EyeQue Corp.
myopia
Ortho-k
vision
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Aug 22, 2022