AmblyopiaNCT04068129
Enhanced Housing Photoscreeners 2WIN and GoCheckKids Compared in Burma and Alaska
An observational study of Amblyopia and Anisometropia, run by Alaska Blind Child Discovery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Anisometropia
- What is being tested?
- photoscreen
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 15 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and young adults attending eye clinics in Burma and Alaska
Who may be able to join
- at least one eye
Who cannot join
- bilateral enucleation
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Children's EYE & Strabismus
Anchorage, Alaska, 99508
About this study
Official title: Performance of Two Photoscreeners With Enhanced Housing
"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.
Read the 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
- Being tested
- photoscreen
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoscreenDevice
Also called refraction
Determine amblyopia risk factors
| Study group | Role | What they receive |
|---|---|---|
| Burma | Patients from remote Burma clinic Receives: Device: photoscreen | |
| Alaska | Patients in pediatric ophthalmology clinic Receives: Device: photoscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amblyopia Rick Factor prevalence
AAPOS 2003 and 2013 defined ARFs
Measured: February 15, 2019 through April 16, 2019
Secondary outcomes (1)
Refractive Error
Glasses prescription
Measured: February 15, 2019 through April 16, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start11 Feb 2019
- Primary completion12 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Arnold, MD, Principal investigator, Alaska Blind Child Discovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068129
- Sponsor's protocol ID
- ABCD GCK Kaleidos
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified data on ABCD website
Publications
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.
PubMed 32546951
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two Photoscreeners With Enhanced Housing
- ClinicalTrials.gov ID
- NCT04068129
- Acronym / sponsor ID
- ABCD GCK Kaleidos
- Conditions
- Amblyopia, Anisometropia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burma | – | Device: photoscreenPatients from remote Burma clinic |
| Alaska | – | Device: photoscreenPatients in pediatric ophthalmology clinic |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults attending eye clinics in Burma and Alaska
Key inclusion criteria (1 listed)
- at least one eye
Key exclusion criteria (1 listed)
- bilateral enucleation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photoscreenAlso: refractionDetermine amblyopia risk factors | Device | Alaska, Burma |
Primary outcome
Amblyopia Rick Factor prevalence
Time frame: February 15, 2019 through April 16, 2019
AAPOS 2003 and 2013 defined ARFs
1 secondary outcome
Refractive Error
Time frame: February 15, 2019 through April 16, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 32546951Martin 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.
- Individual participant dataSharing planned: Yes. de-identified data on ABCD website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Arnold, MD principal investigator
Alaska Blind Child Discovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia and Anisometropia, run by Alaska Blind Child Discovery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amblyopia Rick Factor prevalence (time frame: February 15, 2019 through April 16, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.