Clinical trial NCT03212222: Cell Phone Application for Vision Assessment
Official title: How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Keywords: screening
cell phone application
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 111
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patient randomly assigned to either be screened first with standard clinic technique or cell phone application. Patient is then screened with other method.
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate how visual acuity assessed with Peek Acuity (a cell phone application to check visual acuity) among preschool and school-aged children 3 to less than18 years of age (1) compares to the standard visual acuity exam in the ophthalmology clinic and (2) performs as a screening test for ocular abnormalities that warrant referral for an eye exam.

Detailed description: Current recommendations suggest that children begin visual acuity screening as early as possible with most children capable at 3 years old though some may not be able to cooperate until 4 years of age. While visual acuity screening is standard in schools and pediatric clinics, the specificity of the exams has been questioned. A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children. Because many children who fail these vision screenings are referred to ophthalmology clinics without a true visual acuity deficit, a more accurate but accessible, cost effective, and feasible vision screening exam is necessary. One solution is a smart phone application designed to assess visual acuity, called Peek Acuity. The application is available for android operating system and can be downloaded as a free beta from the Google Play Store. A short tutorial walks users through the application. The application displays a single letter "E" in 4 positions, 0, 90, 180, and 270 degrees (rolling "E") that does not require English comprehension. Patients are instructed to point in the direction of the arms of the "E." The examiner records the responses by swiping the screen in the direction the patient points. The application uses responses to calculate visual acuity and typical exams can be completed within 2 minutes.

In one study, Peek Acuity visual assessments have been shown to be comparable to that determined by the ophthalmology clinic in patients aged 55 years and older. This study also found that the Peek Acuity is efficient, with an average exam time of 77 seconds compared to 82 seconds using the standard Snellen eye chart.

Eligibility criteria: Inclusion Criteria:

* Capable and willing to provide consent
* 3 to less than 18 years of age

Exclusion Criteria:

* Unable or unwilling to give consent
* Over 18 years of age
* Less than 3 years of age

Primary outcomes:
measure: Sensitivity of screening with standard exam vs. Peek Acuity for referral to further medical management
timeFrame: Visit 1 (up to 30 minutes)
measure: Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management
timeFrame: Visit 1 (up to 30 minutes)
measure: Accuracy of screening with standard exam vs. Peek Acuity for referral to further medical management
timeFrame: Visit 1(up to 30 minutes)
Secondary outcomes:
measure: Efficiency of screening with standard exam and Peek Acuity
timeFrame: Visit 1(up to 30 minutes)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke UMC
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah K Jones
role: STUDY_DIRECTOR
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