Visual ImpairmentNCT03212222
Cell Phone Application for Vision Assessment
A study testing Peek Acuity and Standard Visual Screening in people with Visual Impairment, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Peek Acuity and Standard Visual Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Capable and willing to provide consent
- 3 to less than 18 years of age
Who cannot join
- Unable or unwilling to give consent
- Over 18 years of age
- Less than 3 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?
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.
Read the 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 A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children.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
- Being tested
- Peek Acuity, Standard Visual Screening
- Keywords
- screening, cell phone application
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peek AcuityOther
Cell phone application for visual acuity screening
Standard Visual ScreeningOther
Visual screening exam conducted in Duke University Eye Center
| Study group | Role | What they receive |
|---|---|---|
| Peek Acuity Screening | Experimental | Cell phone application to be used for visual acuity screening. Receives: Other: Peek Acuity |
| Standard Visual Screening | Active comparator | Standard visual acuity screening administered at Duke University Eye Center regarded as the gold standard. Receives: Other: Standard Visual Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Visit 1(up to 30 minutes)
Secondary outcomes (1)
Efficiency of screening with standard exam and Peek Acuity
Compare average exam time between standard exam and Peek Acuity
Measured: Visit 1(up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start25 Aug 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah K Jones, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212222
- Sponsor's protocol ID
- Pro00083577
- Status last verified
- Sep 2018
- First submitted
- 5 Jul 2017
- Last updated
- 28 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12812897Miller 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.
PubMed 12939288Anstice 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.
PubMed 22507224Simons 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.
PubMed 8827927Schmucker 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.
PubMed 19669781Alexander 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.
PubMed 19098035Joish 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.
PubMed 12917617Bastawrous 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.
PubMed 26022921Committee 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.
PubMed 12689914Zhao 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.
PubMed 31326117
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Visual Acuity Assessment Using the Peek Acuity Application Compare to the Standard Exam in the Clinic?
- ClinicalTrials.gov ID
- NCT03212222
- Acronym / sponsor ID
- Pro00083577
- Conditions
- Visual Impairment
- Keywords
- screening, cell phone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peek Acuity Screening | Experimental | Other: Peek AcuityCell phone application to be used for visual acuity screening. |
| Standard Visual Screening | Active comparator | Other: Standard Visual ScreeningStandard visual acuity screening administered at Duke University Eye Center regarded as the gold standard. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Capable and willing to provide consent
- 3 to less than 18 years of age
Key exclusion criteria (3 listed)
- Unable or unwilling to give consent
- Over 18 years of age
- Less than 3 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peek AcuityCell phone application for visual acuity screening | Other | Peek Acuity Screening |
| Standard Visual ScreeningVisual screening exam conducted in Duke University Eye Center | Other | Standard Visual Screening |
Primary outcome
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
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
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
1 secondary outcome
Efficiency of screening with standard exam and Peek Acuity
Time frame: Visit 1(up to 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Background: PubMed 12812897Barry 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.
- Background: PubMed 12939288Miller 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.
- Background: PubMed 22507224Anstice 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.
- Background: PubMed 8827927Simons 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.
- Background: PubMed 19669781Schmucker 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.
- Background: PubMed 19098035Alexander 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.
- Background: PubMed 12917617Joish 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.
- Background: PubMed 26022921Bastawrous 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.
- Background: PubMed 12689914Committee 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.
- Derived from this study: PubMed 31326117Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah K Jones study director
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peek Acuity and Standard Visual Screening in people with Visual Impairment, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of screening with standard exam vs. Peek Acuity for referral to further medical management (time frame: Visit 1 (up to 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212222, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.