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

NCT ID: NCT04068129

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2019-04-15

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.

Conditions

Amblyopia; Anisometropia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Burma

Patients from remote Burma clinic

photoscreen

Intervention Type: DEVICE

Determine amblyopia risk factors

Alaska

Patients in pediatric ophthalmology clinic

photoscreen

Intervention Type: DEVICE

Determine amblyopia risk factors

Interventions

photoscreen

Determine amblyopia risk factors

Intervention Type: DEVICE

Other Intervention Names

refraction

Eligibility Criteria

Inclusion Criteria

• at least one eye

Exclusion Criteria

• bilateral enucleation

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alaska Blind Child Discovery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert W Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Alaska Blind Child Discovery

Locations

Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32546951 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

ABCD GCK Kaleidos

Identifier Type: -

Identifier Source: org_study_id