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

Amblyopia Clinical Trial

Official title:

Performance of Two Photoscreeners With Enhanced Housing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068129
• Other study ID #: ABCD GCK Kaleidos
• Status: Completed
• Start date: February 11, 2019
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2019
• Source: Alaska Blind Child Discovery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 15, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 40 Years

Eligibility

Inclusion Criteria:

• at least one eye

Exclusion Criteria:

• bilateral enucleation

Related Conditions & MeSH terms

• Amblyopia
• Anisometropia

Intervention

Device:
• photoscreen
Determine amblyopia risk factors

Locations

Country	Name	City	State
United States	Alaska Children's EYE & Strabismus	Anchorage	Alaska

Sponsors (1)

Lead Sponsor	Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amblyopia Rick Factor prevalence	AAPOS 2003 and 2013 defined ARFs	February 15, 2019 through April 16, 2019
Secondary	Refractive Error	Glasses prescription	February 15, 2019 through April 16, 2019