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Hyperopia Detection GCK With Glow Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297969
Recruitment Status : Completed
First Posted : March 6, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Alaska Blind Child Discovery

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
Amblyopia Bilateral Hyperopia of Both Eyes Astigmatism Bilateral Accommodation Disorder 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.

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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 : October 14, 2019
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Group/Cohort 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 Name: objective pediatric vision screening GCK glow fixation




Primary Outcome Measures :
  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 Outcome Measures :
  1. Amblyopia [ Time Frame: 1 week ]
    Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • Patients having comprehensive pediatric eye examination

Exclusion Criteria:

  • Patients with only one eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297969


Locations
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United States, Alaska
Alaska Children's EYE & Strabismus
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Alaska Blind Child Discovery
Publications:
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Responsible Party: Alaska Blind Child Discovery
ClinicalTrials.gov Identifier: NCT04297969    
Other Study ID Numbers: ABCD GCK Glow
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data via website
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 1 month from now
Access Criteria: Study website
URL: http://www.abcd-vision.org/references/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Amblyopia
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations