CClinicalTrials.gg
Sign In
CompletedNCT04297969Updated Oct 19, 2020

Hyperopia Detection GCK With Glow Fixation

An observational study in Amblyopia Bilateral, Hyperopia of Both Eyes and Astigmatism Bilateral, sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Open to participants aged 1 Month to 20 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Alaska Blind Child Discovery · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
1 Month to 20 Years
Sex
All
01

Study 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."

Read the detailed description

Patients undergoing comprehensive pediatric eye exam were screened with "GoCheck Kids" iPhone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as "Adaptica 2WIN" photoscreener and "Retinomax" auto refraction all without drops before cycloplegia examination.

Reason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted.

Refractive amblyopia risk factors utilizing "AAPOS 2003" and "AAPOS 2013" uniform guidelines were used to validate each screening method.

Patients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.

02

Conditions studied

  • Amblyopia Bilateral
  • Hyperopia of Both Eyes
  • Astigmatism Bilateral
  • Accommodation Disorder
03

Who can participate

Ages eligible
1 Month to 20 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients having comprehensive pediatric eye examination

Exclusion criteria

Exclusion Criteria:

  • Patients with only one eye
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
133 participants (actual)
Patient registry
No

Groups and cohorts

  • GCK Glow fixation

    Patients screened with GoCheck Kids flash concentrated iPhone 7+

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

Interventions

  • Diagnostic testobjective pediatric vision screen "GCK glow fixation"

    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

05

What researchers measure

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

    Time frame: 1 week

Secondary outcomes

  1. Amblyopia

    Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.

    Time frame: 1 week

06

Study locations

1 site
  • Alaska Children's EYE & Strabismus
    Anchorage, Alaska 99508, United States
07

References and documents

Publications

  • 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. PubMed 31539614 ↗
  • 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. PubMed 31077668 ↗
  • 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. PubMed 29305313 ↗
  • 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. PubMed 30197499 ↗
  • 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. PubMed 30160295 ↗
  • 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. PubMed 32982148 ↗
  • 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. PubMed 33505178 ↗

Individual participant data

Plan to share: Yes — de-identified data via website

Supporting information: Csr

08

Registry details

Key details

Study ID
NCT04297969
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Mar 6, 2020
Start date
Oct 14, 2019
Primary completion
Nov 6, 2019
Completion
Mar 3, 2020
Last update
Oct 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Amblyopia→

Other studies from this sponsor

Alaska Blind Child Discovery

Start the discussion