Home Visual Acuity Testing

Overview

About this study

Management of most pediatric eye conditions requires periodic monitoring of visual acuity (VA).
In many cases, particularly the treatment of amblyopia, measurement of VA is the key clinical
outcome of the clinical examination done in the office. However, transporting children and
teenagers to and from the care provider’s office to obtain follow-up measurements of VA can be
difficult due to the need to take time off work and school. In addition, transportation can be a
barrier because of access or cost or both. Additionally, the recent emergence of the COVID-19
pandemic and subsequent global “shelter in place” and “lockdown” precautions have further
highlighted the need for a validated method of measuring VA at home, to enable the monitoring
of eye conditions in the context of telemedicine.
The present study is designed to evaluate whether VA measured at home by a parent or guardian
using the age appropriate ATS-HOTV or e-ETDRS testing protocol on an iPhone-based
application (hereafter referred to as “phone-based” method) will result in measurements similar to
those collected during an office visit at an eye clinic using the same testing protocol on a study
certified EVA or M&S visual acuity tester (hereafter referred to as “office-based” method).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 3 to 17.5 years.
  • If the child wears contact lenses, the child must be able to perform all testing (in office and at home) in spectacle correction without contact lenses.

Eligible families will:

  • Have an iPhone 6 or a later version (excluding first generation iPhone SE) with them at the office visit.
  • The iPhone screen must not have cracks or damage that would decrease legibility of the letters presented (The screen will be checked by a study team member to assure there is no screen damage that would affect legibility of optotypes).
  • Be able to successfully download the age appropriate (ATS-HOTV or e-ETDRS) iPhone application to their iPhone, with assistance from office staff, if needed.
  • Successfully perform the phone-based VA test at the enrollment visit with the participant wearing his/her current optical correction (if worn), with assistance from office staff, if needed.
  • Be able to use the same iPhone to measure VA at home.
  • Be able to have the same adult administer the home VA test for all required home VA tests.
  • Be able and willing to test VA at home 3 days after enrollment (Home test 1) and 1 day after Home test 1 (Home test 2).
  • Be willing to test VA at home within 2 days prior to a subsequent return office visit 3 months after enrollment.
  • Be willing to return for a 3-month office visit.

Participant Exclusion Criteria:

  • Use of atropine in the last 30 days, including the day of enrollment.
  • Use of atropine expected in the upcoming four months.
  • Aphakia (one or both eyes).
  • Dilation and cycloplegia within 48 hours of the first in-office VA measure.
  • Any cognitive or physical limitations of the participant or parent that would limit their.
  • Ability to perform the phone-based testing at home or in-office testing.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erick Bothun, M.D.

Open for enrollment

Contact information:

Suzanne Wernimont CCRP

(507) 293-5060

Wernimont.Suzanne@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20521364

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