Hyperopia Detection GCK With Glow Fixation

October 14, 2020 updated by: Alaska Blind Child Discovery

Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

"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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 20 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

Inclusion Criteria:

  • Patients having comprehensive pediatric eye examination

Exclusion Criteria:

  • Patients with only one eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • objective pediatric vision screening GCK glow fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amblyopia
Time Frame: 1 week
Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaska Blind Child Discovery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Actual)

November 6, 2019

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCD GCK Glow

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identified data via website

IPD Sharing Time Frame

1 month from now

IPD Sharing Access Criteria

Study website

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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