NCT04297969

Hyperopia Detection GCK With Glow Fixation

Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 133 (actual)
• Sponsor: Alaska Blind Child Discovery · Academic / Other
• Sex: All
• Age: 1 Month – 20 Years
• Healthy volunteers: —

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.

Conditions

• Amblyopia Bilateral
• Hyperopia of Both Eyes
• Astigmatism Bilateral
• Accommodation Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	objective pediatric vision screen "GCK glow fixation"	2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device

Timeline

• Start date: 2019-10-14
• Primary completion: 2019-11-06
• Completion: 2020-03-03
• First posted: 2020-03-06
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study