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CompletedNCT04068129Updated Oct 19, 2020

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

An observational study in Amblyopia and Anisometropia, sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Open to participants aged 6 Months to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Alaska Blind Child Discovery · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
162
Ages
6 Months to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Amblyopia
  • Anisometropia
03

Who can participate

Ages eligible
6 Months to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children and young adults attending eye clinics in Burma and Alaska

Inclusion criteria

  • at least one eye

Exclusion criteria

Exclusion Criteria:

  • bilateral enucleation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
162 participants (actual)
Patient registry
No

Groups and cohorts

  • Burma

    Patients from remote Burma clinic

    Device: photoscreen

  • Alaska

    Patients in pediatric ophthalmology clinic

    Device: photoscreen

Interventions

  • Devicephotoscreen

    Determine amblyopia risk factors

    Also known as: refraction

05

What researchers measure

Primary outcomes

  1. Amblyopia Rick Factor prevalence

    AAPOS 2003 and 2013 defined ARFs

    Time frame: February 15, 2019 through April 16, 2019

Secondary outcomes

  1. Refractive Error

    Glasses prescription

    Time frame: February 15, 2019 through April 16, 2019

06

Study locations

1 site
  • Alaska Children's EYE & Strabismus
    Anchorage, Alaska 99508, United States
07

References and documents

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. PubMed 32546951 ↗

Individual participant data

Plan to share: Yes — de-identified data on ABCD website

Supporting information: Csr

08

Registry details

Key details

Study ID
NCT04068129
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
Feb 11, 2019
Primary completion
Apr 12, 2019
Completion
Apr 15, 2019
Last update
Oct 19, 2020

Study contacts

Robert W Arnold, MD
principal investigator · Alaska Blind Child Discovery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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