Cell Phone Application for Vision Assessment

NCT03212222 | Completed

• 1 other identifier: Pro00083577
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Impairment

Keywords

screening; cell phone application

Outcome Measures

Primary Outcomes (3)

• 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

  Visit 1 (up to 30 minutes)

• 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

  Visit 1 (up to 30 minutes)

• 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

  Visit 1(up to 30 minutes)

Secondary Outcomes (1)

• Efficiency of screening with standard exam and Peek Acuity

  Visit 1(up to 30 minutes)

Study Arms (2)

Peek Acuity Screening

EXPERIMENTAL

Cell phone application to be used for visual acuity screening.

Other: Peek Acuity

Standard Visual Screening

ACTIVE COMPARATOR

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

Other: Standard Visual Screening

Interventions

Peek Acuity OTHER

Cell phone application for visual acuity screening

Peek Acuity Screening

Standard Visual Screening OTHER

Visual screening exam conducted in Duke University Eye Center

Standard Visual Screening

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke UMC

Durham, North Carolina, 27710, United States

Location

Related Publications (10)

• 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.

  PMID: 12812897 BACKGROUND

• 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.

  PMID: 12939288 BACKGROUND

• 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.

  PMID: 22507224 BACKGROUND

• 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.

  PMID: 8827927 BACKGROUND

• 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.

  PMID: 19669781 BACKGROUND

• 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.

  PMID: 19098035 BACKGROUND

• 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.

  PMID: 12917617 BACKGROUND

• 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.

  PMID: 26022921 BACKGROUND

• 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.

  PMID: 12689914 BACKGROUND

• 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.

  PMID: 31326117 DERIVED

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah K Jones

  Duke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient randomly assigned to either be screened first with standard clinic technique or cell phone application. Patient is then screened with other method.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: August 25, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: June 28, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)