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Completed

NCT Number: NCT04297969

Hyperopia Detection GCK With Glow Fixation

"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."

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Key information

Conditions

Amblyopia Bilateral Accommodation Disorder Astigmatism Bilateral Hyperopia of Both Eyes

Age range

1 month–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients having comprehensive pediatric eye examination

Exclusion criteria

  • Patients with only one eye

Treatment and study plan

objective pediatric vision screen "GCK glow fixation"

Diagnostic Test

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

Other names: objective pediatric vision screening GCK glow fixation

Primary outcomes

  1. 2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence

    Time frame: 1 week

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

Secondary outcomes

  1. Amblyopia

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Official study title

Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 6, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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