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

Performance of Two Photoscreeners With Enhanced Housing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04068129
Enrollment
162
Registered
2019-08-28
Start date
2019-02-11
Completion date
2019-04-15
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Anisometropia

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.

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.

Interventions

DEVICEphotoscreen

Determine amblyopia risk factors

Sponsors

Alaska Blind Child Discovery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* at least one eye

Exclusion criteria

* bilateral enucleation

Design outcomes

Primary

MeasureTime frameDescription
Amblyopia Rick Factor prevalenceFebruary 15, 2019 through April 16, 2019AAPOS 2003 and 2013 defined ARFs

Secondary

MeasureTime frameDescription
Refractive ErrorFebruary 15, 2019 through April 16, 2019Glasses prescription

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026