NCT04297969

Brief Summary

"GoCheck Kids" has added to its iPhone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. In pediatric eye patients, the "GCK" with glow box is compared to cycloplegic refraction as well as School Bus Accommodation-relaxing skiascopy, "2WIN" photoscreener and "Retinomax."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

October 19, 2020

Status Verified

March 1, 2020

Enrollment Period

23 days

First QC Date

March 4, 2020

Last Update Submit

October 14, 2020

Conditions

Amblyopia BilateralHyperopia of Both EyesAstigmatism BilateralAccommodation Disorder

Outcome Measures

Primary Outcomes (1)

  • 2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence

    presence of refractive risk factors (anisometropia \>1.50D, hyperopia \> 3.5D, Astigmatism \>1.50D, myopia more than 3D

    1 week

Secondary Outcomes (1)

  • Amblyopia

    1 week

Study Arms (1)

GCK Glow fixation

Patients screened with GoCheck Kids flash concentrated iPhone 7+

Diagnostic Test: objective pediatric vision screen "GCK glow fixation"

Interventions

objective pediatric vision screen "GCK glow fixation"DIAGNOSTIC_TEST

2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device

Also known as: objective pediatric vision screening GCK glow fixation
GCK Glow fixation

Eligibility Criteria

Age1 Month - 20 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with a range of refractive errors including high hyperopia and astigmatism in a pediatric ophthalmology referral practice.

You may qualify if:

  • Patients having comprehensive pediatric eye examination

You may not qualify if:

  • Patients with only one eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

Location

Related Publications (7)

  • Racano E, Alessi S, Pertile R. Comparison of 2Win and plusoptiX A12R refractometers with Retinomax handheld autorefractor keratometer. J AAPOS. 2019 Oct;23(5):276.e1-276.e5. doi: 10.1016/j.jaapos.2019.05.017. Epub 2019 Sep 17.

    PMID: 31539614BACKGROUND

  • Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.

    PMID: 31077668BACKGROUND

  • Peterseim MMW, Rhodes RS, Patel RN, Wilson ME, Edmondson LE, Logan SA, Cheeseman EW, Shortridge E, Trivedi RH. Effectiveness of the GoCheck Kids Vision Screener in Detecting Amblyopia Risk Factors. Am J Ophthalmol. 2018 Mar;187:87-91. doi: 10.1016/j.ajo.2017.12.020. Epub 2018 Jan 2.

    PMID: 29305313BACKGROUND

  • Arnold RW, O'Neil JW, Cooper KL, Silbert DI, Donahue SP. Evaluation of a smartphone photoscreening app to detect refractive amblyopia risk factors in children aged 1-6 years. Clin Ophthalmol. 2018 Aug 23;12:1533-1537. doi: 10.2147/OPTH.S171935. eCollection 2018.

    PMID: 30197499BACKGROUND

  • Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29.

    PMID: 30160295BACKGROUND

  • Levitt AH, Martin SJ, Arnold RW. Performance of Glow Fixation GoCheck Kids and 2WIN Photoscreeners and Retinomax to Uncover Hyperopia. Clin Ophthalmol. 2020 Aug 10;14:2237-2244. doi: 10.2147/OPTH.S256991. eCollection 2020.

    PMID: 32982148BACKGROUND

  • Arnold RW, Beveridge JS, Martin SJ, Beveridge NR, Metzger EJ, Smith KA. Grading Sphero-Cylinder Spectacle Similarity. Clin Optom (Auckl). 2021 Jan 20;13:23-32. doi: 10.2147/OPTO.S289770. eCollection 2021.

    PMID: 33505178DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

October 14, 2019

Primary Completion

November 6, 2019

Study Completion

March 3, 2020

Last Updated

October 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

de-identified data via website

Shared Documents
CSR
Time Frame
1 month from now
Access Criteria
Study website
More information

Locations

US(1)