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Hyperopia Detection GCK With Glow Fixation

Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04297969
Enrollment
133
Registered
2020-03-06
Start date
2019-10-14
Completion date
2020-03-03
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accommodation Disorder, Amblyopia Bilateral, Astigmatism Bilateral, Hyperopia of Both Eyes

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.

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.

Interventions

DIAGNOSTIC_TESTobjective pediatric vision screen GCK glow fixation

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

Sponsors

Alaska Blind Child Discovery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 20 Years

Inclusion criteria

* Patients having comprehensive pediatric eye examination

Exclusion criteria

* Patients with only one eye

Design outcomes

Primary

MeasureTime frameDescription
2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence1 weekpresence of refractive risk factors (anisometropia \>1.50D, hyperopia \> 3.5D, Astigmatism \>1.50D, myopia more than 3D

Secondary

MeasureTime frameDescription
Amblyopia1 weekPresence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026