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

NCT04693260 | Completed FDA Device

• 1 other identifier: EYEQUE - 007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia; Ortho-k; vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure rapidly changing visual acuity

  Approximately 21 Weeks

Study Arms (1)

Hand-held Device Supported by Mobile Application

OTHER

Insight device ETDRS measurement compared to a standard ETDRS chart

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

Interventions

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

The Insight will be compared to a standard ETDRS eyechart

Hand-held Device Supported by Mobile Application

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EyeQue Corp.: lead
• Eye Boutique Optometry: collaborator

Study Sites (1)

Eye Boutique Optometry

Santa Clara, California, 95051, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: July 3, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)