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OpenTrials
Completed

NCT Number: NCT04693260

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

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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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Boutique Optometry

Santa Clara, California, 95051, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

The Insight will be compared to a standard ETDRS eyechart

Primary outcomes

  1. Departure from scheduled follow-up visits with clinical confirmation

    Time frame: 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 outcomes

  1. Measure rapidly changing visual acuity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EyeQue Corp.

Industry

Collaborators

  • Eye Boutique Optometry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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