Hyperopia Detection GCK With Glow Fixation

Completed

• Conditions: Amblyopia Bilateral; Hyperopia of Both Eyes; Astigmatism Bilateral; Accommodation Disorder
• Interventions: Diagnostic Test: objective pediatric vision screen "GCK glow fixation"

• Registration Number: NCT04297969
• Lead Sponsor: 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."

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 Timeline

• Study Start: 2019-10-14
• Primary Completion: 2019-11-06
• Status Verified: 2020-03
• Study Completion: 2020-03-03
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• Patients having comprehensive pediatric eye examination

Exclusion Criteria

• Patients with only one eye

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GCK Glow fixation	objective pediatric vision screen "GCK glow fixation"	Patients screened with GoCheck Kids flash concentrated iPhone 7+

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Amblyopia	1 week	Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.

Trial Locations

Locations (1)

Alaska Children's EYE & Strabismus; 🇺🇸 Anchorage, Alaska, United States