Clinical trial NCT04068129: Enhanced Housing Photoscreeners 2WIN and GoCheckKids Compared in Burma and Alaska
Official title: Performance of Two Photoscreeners With Enhanced Housing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Anisometropia
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 162
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults attending eye clinics in Burma and Alaska

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.

Eligibility criteria: Inclusion Criteria:

* at least one eye

Exclusion Criteria:

* bilateral enucleation

Primary outcomes:
measure: Amblyopia Rick Factor prevalence
timeFrame: February 15, 2019 through April 16, 2019
Secondary outcomes:
measure: Refractive Error
timeFrame: February 15, 2019 through April 16, 2019
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's EYE & Strabismus
state: Alaska
Study officials:
affiliation: Alaska Blind Child Discovery
name: Robert W Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.