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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Performance of Two Photoscreeners With Enhanced Housing

Conditions
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Amblyopia, Anisometropia

Intervention / Treatment
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* Device: photoscreen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one eye Exclusion Criteria: bilateral enucleation

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Burma<br>Patients from remote Burma clinic | Device: photoscreen<br>* Determine amblyopia risk factors<br>* Other names: refraction;|
| Alaska<br>Patients in pediatric ophthalmology clinic | Device: photoscreen<br>* Determine amblyopia risk factors<br>* Other names: refraction;|

What is the study measuring?
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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 |