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OpenTrials
Completed

NCT Number: NCT03212222

Cell Phone Application for Vision Assessment

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke UMC

Durham, North Carolina, 27710, United States

About this study

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peek Acuity

Other

Cell phone application for visual acuity screening

Standard Visual Screening

Other

Visual screening exam conducted in Duke University Eye Center

Primary outcomes

  1. Sensitivity of screening with standard exam vs. Peek Acuity for referral to further medical management

    Time frame: Visit 1 (up to 30 minutes)

    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

  2. Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management

    Time frame: Visit 1 (up to 30 minutes)

    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

  3. Accuracy of screening with standard exam vs. Peek Acuity for referral to further medical management

    Time frame: Visit 1(up to 30 minutes)

    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

Secondary outcomes

  1. Efficiency of screening with standard exam and Peek Acuity

    Time frame: Visit 1(up to 30 minutes)

    Compare average exam time between standard exam and Peek Acuity

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.