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Cell Phone Application for Vision Assessment

Primary Purpose

Visual Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peek Acuity
Standard Visual Screening
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Visual Impairment focused on measuring screening, cell phone application

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke UMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peek Acuity Screening

Standard Visual Screening

Arm Description

Cell phone application to be used for visual acuity screening.

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

Outcomes

Primary Outcome Measures

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

Efficiency of screening with standard exam and Peek Acuity
Compare average exam time between standard exam and Peek Acuity

Full Information

First Posted
July 5, 2017
Last Updated
June 27, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03212222
Brief Title
Cell Phone Application for Vision Assessment
Official Title
How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment
Keywords
screening, cell phone application

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peek Acuity Screening
Arm Type
Experimental
Arm Description
Cell phone application to be used for visual acuity screening.
Arm Title
Standard Visual Screening
Arm Type
Active Comparator
Arm Description
Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard.
Intervention Type
Other
Intervention Name(s)
Peek Acuity
Intervention Description
Cell phone application for visual acuity screening
Intervention Type
Other
Intervention Name(s)
Standard Visual Screening
Intervention Description
Visual screening exam conducted in Duke University Eye Center
Primary Outcome Measure Information:
Title
Sensitivity of screening with standard exam vs. Peek Acuity for referral to further medical management
Description
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
Time Frame
Visit 1 (up to 30 minutes)
Title
Specificity of screening with standard exam vs. Peek Acuity for referral to further medical management
Description
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
Time Frame
Visit 1 (up to 30 minutes)
Title
Accuracy of screening with standard exam vs. Peek Acuity for referral to further medical management
Description
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
Time Frame
Visit 1(up to 30 minutes)
Secondary Outcome Measure Information:
Title
Efficiency of screening with standard exam and Peek Acuity
Description
Compare average exam time between standard exam and Peek Acuity
Time Frame
Visit 1(up to 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K Jones
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke UMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12812897
Citation
Barry JC, Konig HH. Test characteristics of orthoptic screening examination in 3 year old kindergarten children. Br J Ophthalmol. 2003 Jul;87(7):909-16. doi: 10.1136/bjo.87.7.909. Erratum In: Br J Ophthalmol. 2003 Sep;87(9):1196.
Results Reference
background
PubMed Identifier
12939288
Citation
Miller JM, Dobson V, Harvey EM, Sherrill DL. Cost-efficient vision screening for astigmatism in native american preschool children. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):3756-63. doi: 10.1167/iovs.02-0970.
Results Reference
background
PubMed Identifier
22507224
Citation
Anstice N, Spink J, Abdul-Rahman A. Review of preschool vision screening referrals in South Auckland, New Zealand. Clin Exp Optom. 2012 Jul;95(4):442-8. doi: 10.1111/j.1444-0938.2012.00713.x. Epub 2012 Apr 17.
Results Reference
background
PubMed Identifier
8827927
Citation
Simons K. Preschool vision screening: rationale, methodology and outcome. Surv Ophthalmol. 1996 Jul-Aug;41(1):3-30. doi: 10.1016/s0039-6257(97)81990-x.
Results Reference
background
PubMed Identifier
19669781
Citation
Schmucker C, Grosselfinger R, Riemsma R, Antes G, Lange S, Lagreze W, Kleijnen J. Diagnostic accuracy of vision screening tests for the detection of amblyopia and its risk factors: a systematic review. Graefes Arch Clin Exp Ophthalmol. 2009 Nov;247(11):1441-54. doi: 10.1007/s00417-009-1150-2. Epub 2009 Aug 11.
Results Reference
background
PubMed Identifier
19098035
Citation
Alexander P, Rahi JS, Hingorani M. Provision and cost of children's and young people's eye services in the UK: findings from a single primary care trust. Br J Ophthalmol. 2009 May;93(5):645-9. doi: 10.1136/bjo.2008.149203. Epub 2008 Dec 19.
Results Reference
background
PubMed Identifier
12917617
Citation
Joish VN, Malone DC, Miller JM. A cost-benefit analysis of vision screening methods for preschoolers and school-age children. J AAPOS. 2003 Aug;7(4):283-90. doi: 10.1016/s1091-8531(03)00116-2.
Results Reference
background
PubMed Identifier
26022921
Citation
Bastawrous A, Rono HK, Livingstone IA, Weiss HA, Jordan S, Kuper H, Burton MJ. Development and Validation of a Smartphone-Based Visual Acuity Test (Peek Acuity) for Clinical Practice and Community-Based Fieldwork. JAMA Ophthalmol. 2015 Aug;133(8):930-7. doi: 10.1001/jamaophthalmol.2015.1468. Erratum In: JAMA Ophthalmol. 2015 Sep;133(9):1096.
Results Reference
background
PubMed Identifier
12689914
Citation
Committee on Practice and Ambulatory Medicine Section on Ophthalmology; American Association of Certified Orthoptists; American Association for Pediatric Ophthalmology and Strabismus; American Academy of Ophthalmology. Eye examination in infants, children, and young adults by pediatricians: organizational principles to guide and define the child health care system and/or improve the health of all children. Ophthalmology. 2003 Apr;110(4):860-5. doi: 10.1016/S0161-6420(03)00414-7.
Results Reference
background
PubMed Identifier
31326117
Citation
Zhao L, Stinnett SS, Prakalapakorn SG. Visual Acuity Assessment and Vision Screening Using a Novel Smartphone Application. J Pediatr. 2019 Oct;213:203-210.e1. doi: 10.1016/j.jpeds.2019.06.021. Epub 2019 Jul 18.
Results Reference
derived

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Cell Phone Application for Vision Assessment

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