Hyperopia Detection GCK With Glow Fixation

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Completed
CT.gov ID
NCT04297969
Collaborator
(none)
133
1
4.6
28.7

Study Details

Study Description

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."

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: objective pediatric vision screen "GCK glow fixation"

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.

Study Design

Study Type:
Observational
Actual Enrollment :
133 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device
Actual Study Start Date :
Oct 14, 2019
Actual Primary Completion Date :
Nov 6, 2019
Actual Study Completion Date :
Mar 3, 2020

Arms and Interventions

Arm Intervention/Treatment
GCK Glow fixation

Patients screened with GoCheck Kids flash concentrated iPhone 7+

Diagnostic Test: objective pediatric vision screen "GCK glow fixation"
2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device
Other Names:
  • objective pediatric vision screening GCK glow fixation
  • Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

    1. Amblyopia [1 week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 20 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients having comprehensive pediatric eye examination
    Exclusion Criteria:
    • Patients with only one eye

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Children's EYE & Strabismus Anchorage Alaska United States 99508

    Sponsors and Collaborators

    • Alaska Blind Child Discovery

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaska Blind Child Discovery
    ClinicalTrials.gov Identifier:
    NCT04297969
    Other Study ID Numbers:
    • ABCD GCK Glow
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2020