Cell Phone Application for Vision Assessment

Visual Impairment Clinical Trial

Official title:

How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212222
• Other study ID #: Pro00083577
• Status: Completed
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: September 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Peek Acuity
Cell phone application for visual acuity screening
• Standard Visual Screening
Visual screening exam conducted in Duke University Eye Center

Locations

Country	Name	City	State
United States	Duke UMC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View Citation

Barry JC, König HH. Test characteristics of orthoptic screening examination in 3 year old kindergarten children. Br J Ophthalmol. 2003 Jul;87(7):909-16. Erratum in: Br J Ophthalmol. 2003 Sep;87(9):1196. — View 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. — View 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. — View 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. — View 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. — View Citation

Schmucker C, Grosselfinger R, Riemsma R, Antes G, Lange S, Lagrèze 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. Review. — View Citation

Simons K. Preschool vision screening: rationale, methodology and outcome. Surv Ophthalmol. 1996 Jul-Aug;41(1):3-30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Efficiency of screening with standard exam and Peek Acuity	Compare average exam time between standard exam and Peek Acuity	Visit 1(up to 30 minutes)