Cell Phone Application for Vision Assessment

Study Overview
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Brief Summary
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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
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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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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.

Official Title
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How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?

Conditions
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Visual Impairment

Intervention / Treatment
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* Other: Peek Acuity
* Other: Standard Visual Screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peek Acuity Screening<br>Cell phone application to be used for visual acuity screening. | Other: Peek Acuity<br>* Cell phone application for visual acuity screening<br>|
| Active Comparator: Standard Visual Screening<br>Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard. | Other: Standard Visual Screening<br>* Visual screening exam conducted in Duke University Eye Center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of screening with standard exam vs. Peek Acuity for referral to further medical management | Children screened positive for visual deficit by standard exam will be deemed true positives; any true positives not identified by the Peek Acuity application will be deemed false negatives. Sensitivity is calculated by true positive population divided by the sum of true positives and false negatives | Visit 1 (up to 30 minutes) | 
| Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management | Children screened negative for visual deficit by standard exam will be deemed true negatives; any true negatives not identified by the Peek Acuity application will be deemed false positives. Specificity is calculated by true negative population divided by the sum of true negatives and false positives | Visit 1 (up to 30 minutes) | 
| Accuracy of screening with standard exam vs. Peek Acuity for referral to further medical management | Visual acuity score determined by Peek Acuity will be compared to the score from standard exam to determine accuracy where the score from standard exam is the accepted value | Visit 1(up to 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of screening with standard exam and Peek Acuity | Compare average exam time between standard exam and Peek Acuity | Visit 1(up to 30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, cell phone application