Cell Phone Application for Vision Assessment

NCT ID: NCT03212222

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-25
• Study Completion Date: 2017-12-15

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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

Conditions

Visual Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Peek Acuity Screening

Cell phone application to be used for visual acuity screening.

Group Type: EXPERIMENTAL

Peek Acuity

Intervention Type: OTHER

Cell phone application for visual acuity screening

Standard Visual Screening

Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard.

Group Type: ACTIVE_COMPARATOR

Standard Visual Screening

Intervention Type: OTHER

Visual screening exam conducted in Duke University Eye Center

Interventions

Peek Acuity

Cell phone application for visual acuity screening

Intervention Type: OTHER

Standard Visual Screening

Visual screening exam conducted in Duke University Eye Center

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah K Jones

Role: STUDY_DIRECTOR

Duke University

Locations

Duke UMC

Durham, North Carolina, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 31326117 (View on PubMed)

Other Identifiers

Pro00083577

Identifier Type: -

Identifier Source: org_study_id