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Clinical Trials/NCT03212222
NCT03212222
Completed
Not Applicable

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

Duke University1 site in 1 country111 target enrollmentAugust 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Impairment
Sponsor
Duke University
Enrollment
111
Locations
1
Primary Endpoint
Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management
Status
Completed
Last Updated
6 years ago

Overview

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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

Registry
clinicaltrials.gov
Start Date
August 25, 2017
End Date
December 15, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Efficiency of screening with standard exam and Peek Acuity(Visit 1(up to 30 minutes))

Study Sites (1)

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