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

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ClinicalTrials.gov Identifier: NCT04068129
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Alaska Blind Child Discovery

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
Amblyopia Anisometropia 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.

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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 : February 11, 2019
Actual Primary Completion Date : April 12, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Group/Cohort Intervention/treatment
Burma
Patients from remote Burma clinic
Device: photoscreen
Determine amblyopia risk factors
Other Name: refraction

Alaska
Patients in pediatric ophthalmology clinic
Device: photoscreen
Determine amblyopia risk factors
Other Name: refraction




Primary Outcome Measures :
  1. Amblyopia Rick Factor prevalence [ Time Frame: February 15, 2019 through April 16, 2019 ]
    AAPOS 2003 and 2013 defined ARFs


Secondary Outcome Measures :
  1. Refractive Error [ Time Frame: February 15, 2019 through April 16, 2019 ]
    Glasses prescription



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults attending eye clinics in Burma and Alaska
Criteria

Inclusion Criteria:

  • at least one eye

Exclusion Criteria:

  • bilateral enucleation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068129


Locations
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United States, Alaska
Alaska Children's EYE & Strabismus
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Alaska Blind Child Discovery
Investigators
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Principal Investigator: Robert W Arnold, MD Alaska Blind Child Discovery
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Alaska Blind Child Discovery
ClinicalTrials.gov Identifier: NCT04068129    
Other Study ID Numbers: ABCD GCK Kaleidos
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data on ABCD website
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Fall 2019
Access Criteria: ongoing
URL: http://www.abcd-vision.org/references/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Amblyopia
Anisometropia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Refractive Errors