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Cell Phone Application for Vision Assessment

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ClinicalTrials.gov Identifier: NCT03212222
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Visual Impairment Other: Peek Acuity Other: Standard Visual Screening Not Applicable

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : August 3, 2018
Estimated Study Completion Date : August 3, 2018

Arm Intervention/treatment
Experimental: Peek Acuity Screening
Cell phone application to be used for visual acuity screening.
Other: Peek Acuity
Cell phone application for visual acuity screening

Active Comparator: Standard Visual Screening
Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard.
Other: Standard Visual Screening
Visual screening exam conducted in Duke University Eye Center




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212222


Contacts
Contact: Sasapin Prakalapakorn, MD 919-684-7679 grace.prakalapakorn@duke.edu

Locations
United States, North Carolina
Duke UMC Recruiting
Durham, North Carolina, United States, 27710
Contact: Sasapin G Prakalapakorn, MD, MPH    919-684-7679    grace.prakalapakorn@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Study Director: Sarah K Jones Duke University

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03212222     History of Changes
Other Study ID Numbers: Pro00083577
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
screening
cell phone application

Additional relevant MeSH terms:
Vision Disorders
Vision, Low
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms