Myopia
Conditions
Keywords
myopia, Ortho-k, vision
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.
Interventions
DEVICEVisual Acuity with a Hand-held Device Supported by Mobile App.
The Insight will be compared to a standard ETDRS eyechart
Sponsors
Eye Boutique Optometry
EyeQue Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
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: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed