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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Visual Acuity with a Hand-held Device Supported by Mobile App.

• Registration Number: NCT04693260
• Lead Sponsor: EyeQue Corp.

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.

Study Timeline

• Study Start: 2020-07-03
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand-held Device Supported by Mobile Application	Visual Acuity with a Hand-held Device Supported by Mobile App.	Insight device ETDRS measurement compared to a standard ETDRS chart

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Eye Boutique Optometry; 🇺🇸 Santa Clara, California, United States