Cell Phone Application for Vision Assessment

Not Applicable

Completed

• Conditions: Visual Impairment
• Interventions: Other: Standard Visual Screening; Other: Peek Acuity

• Registration Number: NCT03212222
• Lead Sponsor: Duke University

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-08-25
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-09
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Visual Screening	Standard Visual Screening	Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard.
Peek Acuity Screening	Peek Acuity	Cell phone application to be used for visual acuity screening.

Primary Outcome Measures

Name	Time	Method
Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management	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	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	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 Outcome Measures

Name	Time	Method
Efficiency of screening with standard exam and Peek Acuity	Visit 1(up to 30 minutes)	Compare average exam time between standard exam and Peek Acuity

Trial Locations

Locations (1)

Duke UMC; 🇺🇸 Durham, North Carolina, United States