Enhanced Housing Photoscreeners 2WIN and GoCheckKids Compared in Burma and Alaska

NCT04068129 | Completed FDA Device

• 1 other identifier: ABCD GCK Kaleidos
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

"Adaptica" (Padova, Italy) designed a fixed-distance, dark portable tube with power and remote control for the "2WIN: photoscreener. GoChecksKids designed a flash-concentrating case for the iPhone 7+ to more quickly achieve two-axis photoscreen. These devices were compared to confirmatory exams in children and young adults in a remote Burma clinic and in an Alaskan pediatric ophthalmology practice.

Conditions

Amblyopia; Anisometropia

Outcome Measures

Primary Outcomes (1)

• Amblyopia Rick Factor prevalence

  AAPOS 2003 and 2013 defined ARFs

  February 15, 2019 through April 16, 2019

Secondary Outcomes (1)

• Refractive Error

  February 15, 2019 through April 16, 2019

Study Arms (2)

Burma

Patients from remote Burma clinic

Device: photoscreen

Alaska

Patients in pediatric ophthalmology clinic

Device: photoscreen

Interventions

photoscreen DEVICE

Determine amblyopia risk factors

Also known as: refraction

Alaska; Burma

Eligibility Criteria

• Age: 6 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and young adults attending eye clinics in Burma and Alaska

You may qualify if:

• at least one eye

You may not qualify if:

• bilateral enucleation

Sponsors & Collaborators

• Alaska Blind Child Discovery: lead

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

Location

Related Publications (1)

• Martin SJ, Htoo HE, Hser N, Arnold RW. Performance of Two Photoscreeners Enhanced by Protective Cases. Clin Ophthalmol. 2020 May 25;14:1427-1435. doi: 10.2147/OPTH.S251451. eCollection 2020.

  PMID: 32546951 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Anisometropia

Interventions

Refraction, Ocular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Optical Phenomena; Physical Phenomena; Ocular Physiological Phenomena

Study Officials

• Robert W Arnold, MD

  Alaska Blind Child Discovery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: February 11, 2019
• Primary Completion: April 12, 2019
• Study Completion: April 15, 2019
• Last Updated: October 19, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Fall 2019
• Access Criteria: ongoing

Locations

US (1)