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

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Completed
CT.gov ID
NCT04068129
Collaborator
(none)
162
1
2.1
78.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
162 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Performance of Two Photoscreeners With Enhanced Housing
Actual Study Start Date :
Feb 11, 2019
Actual Primary Completion Date :
Apr 12, 2019
Actual Study Completion Date :
Apr 15, 2019

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Amblyopia Rick Factor prevalence [February 15, 2019 through April 16, 2019]

      AAPOS 2003 and 2013 defined ARFs

    Secondary Outcome Measures

    1. Refractive Error [February 15, 2019 through April 16, 2019]

      Glasses prescription

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • at least one eye
    Exclusion Criteria:
    • bilateral enucleation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Children's EYE & Strabismus Anchorage Alaska United States 99508

    Sponsors and Collaborators

    • Alaska Blind Child Discovery

    Investigators

    • Principal Investigator: Robert W Arnold, MD, Alaska Blind Child Discovery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaska Blind Child Discovery
    ClinicalTrials.gov Identifier:
    NCT04068129
    Other Study ID Numbers:
    • ABCD GCK Kaleidos
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2020