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

Performance of Two Photoscreeners With Enhanced Housing

"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.

Study Overview

• Status: Completed
• Conditions: Amblyopia; Anisometropia
• Intervention / Treatment: Device: photoscreen

Detailed Description

Photoscreening with follow up confirmatory exams for referred and passed interpretations were offered to children and young adults at a remote clinic in the Karen State of eastern Burma (Myanmar). The clinic had intermittent 220 Volt power generator, but no internet or cell phone coverage.

Consecutive patients in a "WiFi-equipped" pediatric ophthalmology practice in Anchorage, Alaska had photoscreening before confirmatory examination.

Each patient had photoscreening with the "2WIN" photoscreener installed in the "Kaleidos" housing. In Anchorage, the devise was controled by the wireless tablet computer. In Burma, however, despite a "WiFi router" not connected to internet, the tablet computer would not connect to the 2WIN and therefore the "Kaleidos" read-trap door was opened so the 2WIN could be activated and controlled manually. The" 2WIN" stored results on an "micro-SD" memory card which was eventually downloaded to computer.

Each patient also had photoscreening with GoCheckKids (GCK) on an "iPhone 7 Plus" using the enhanced, flash-concentrating cell-phone case. In Anchorage, in addition to on-site smart-phone interpretation, images were uploaded to the central reading center for secondary interpretation. In Burma, all images were retained on the smart phone and eventually uploaded for GoCheckKids central secondary analysis after return to urban internet availability. In Burma, a portable, light-wieght tent was used to provide a dim screening environment with less distraction.

Confirmatory exams were performed consistent with 2003 and 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) uniform guidelines. Cycloplegic refractions were performed 20-40 minutes after cyclopentolate 1% instillation. Visual acuity was checked with patched, surround "HOTV" at 3 meters threshold with at least 3 of 4 optotypes correct. Validation was performed with conventional 2 x 2 screen-exam matrix, and also with Alaska Blind Child Discovery (ABCD) 3 x 3 matrix including inconclusive results (no instrument interpretation or unable to gain a reading) with inconclusive interpretations considered a referral.

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and young adults attending eye clinics in Burma and Alaska

Description

Inclusion Criteria:

• at least one eye

Exclusion Criteria:

• bilateral enucleation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Burma; Patients from remote Burma clinic	Device: photoscreen; Determine amblyopia risk factors; Other Names: refraction
Alaska; Patients in pediatric ophthalmology clinic	Device: photoscreen; Determine amblyopia risk factors; Other Names: refraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amblyopia Rick Factor prevalence	AAPOS 2003 and 2013 defined ARFs	February 15, 2019 through April 16, 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive Error	Glasses prescription	February 15, 2019 through April 16, 2019

Collaborators and Investigators

• Sponsor: Alaska Blind Child Discovery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders; Amblyopia; Anisometropia
• Other Study ID Numbers: ABCD GCK Kaleidos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data on ABCD website
• IPD Sharing Time Frame: Fall 2019
• IPD Sharing Access Criteria: ongoing
• IPD Sharing Supporting Information Type: CSR

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes