Refractive Errors2WINbusNCT03668067
Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines
An observational study of Refractive Errors and Amblyopia, run by Alaska Blind Child Discovery at 1 site in United States.
Trial summary
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors. Read more about this study
- Who is it for?
- Ages 1 week to 90 years
- Conditions the study is for
- Refractive Errors, Amblyopia, Strabismus
- What is being tested?
- 2WIN photoscreener
- Type of treatment
- Medical device
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 31 Oct 2018
- How long will I take part?
- 1 Day
- 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 1 week to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: male and female children and adults with strabismus developmental delay is NOT excluded
Who may be able to join
- patient undergoing eye examination
Who cannot join
- none
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: Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.
Read the detailed description
Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.
Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN) ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction.
Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus.
Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines.
Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.
- Conditions
- Refractive Errors, Amblyopia, Strabismus, Development Delay
- Being tested
- 2WIN photoscreener
- Medical subject headings
- Refractive Errors, Amblyopia, Strabismus, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2WIN photoscreenerDevice
conventional infrared off-axis photoscreener
| Study group | Role | What they receive |
|---|---|---|
| Photoscreener (2WIN) | Accommodation, refraction and ocular alignment are estimated by infrared photoscreener using the photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera. Receives: Device: 2WIN photoscreener | |
| school bus skiascopy | Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amblyopia Risk Factor (refractive error and/or strabismus)
Whether pre-defined, age-related risk factor is present. AAPOS has published standard levels of these refractive errors or binocular misalignment that render a child at risk of developing sight-threatening amblyopia.
Measured: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start2 Apr 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies 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
- 471 participants (actual)
- Target duration
- 1 Day
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
- NCT03668067
- Sponsor's protocol ID
- ABCD 2WIN bus
- Acronym
- 2WINbus
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2018
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified database on-line available
Publications
Tsao Wu M, Armitage MD, Trujillo C, Trujillo A, Arnold LE, Tsao Wu L, Arnold RW. Portable acuity screening for any school: validation of patched HOTV with amblyopic patients and Bangerter normals. BMC Ophthalmol. 2017 Dec 4;17(1):232. doi: 10.1186/s12886-017-0624-y.
PubMed 29202721Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.
PubMed 23360915Arnold RW, Davis B, Arnold LE, Rowe KS, Davis JM. Calibration and validation of nine objective vision screeners with contact lens-induced anisometropia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):184-90. doi: 10.3928/01913913-20130402-02. Epub 2013 Apr 9.
PubMed 23565714Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29.
PubMed 30160295Kirk S, Armitage MD, Dunn S, Arnold RW. Calibration and validation of the 2WIN photoscreener compared to the PlusoptiX S12 and the SPOT. J Pediatr Ophthalmol Strabismus. 2014 Sep-Oct;51(5):289-92. doi: 10.3928/01913913-20140701-01. Epub 2014 Jul 8.
PubMed 25000209Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
PubMed 31077668Arnold AW, Arnold SL, Sprano JH, Arnold RW. School bus accommodation-relaxing skiascopy. Clin Ophthalmol. 2019 Oct 8;13:1841-1851. doi: 10.2147/OPTH.S219031. eCollection 2019.
PubMed 31631961
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy
- ClinicalTrials.gov ID
- NCT03668067
- Acronym / sponsor ID
- 2WINbus / ABCD 2WIN bus
- Conditions
- Refractive Errors, Amblyopia, Strabismus, Development Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Sep 2018 (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.
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.
Detailed description
Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.
Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN) ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction.
Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus.
Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines.
Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photoscreener (2WIN) | – | Device: 2WIN photoscreenerAccommodation, refraction and ocular alignment are estimated by infrared photoscreener using the photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera. |
| school bus skiascopy | – | –Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy. |
Who may qualify
- Ages
- 1 week to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- male and female children and adults with strabismus developmental delay is NOT excluded
Key inclusion criteria (1 listed)
- patient undergoing eye examination
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| 2WIN photoscreenerconventional infrared off-axis photoscreener | Device | Photoscreener (2WIN) |
Primary outcome
Amblyopia Risk Factor (refractive error and/or strabismus)
Time frame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.
Whether pre-defined, age-related risk factor is present. AAPOS has published standard levels of these refractive errors or binocular misalignment that render a child at risk of developing sight-threatening amblyopia.
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 30 Jan 2024.
- Background: PubMed 29202721Tsao Wu M, Armitage MD, Trujillo C, Trujillo A, Arnold LE, Tsao Wu L, Arnold RW. Portable acuity screening for any school: validation of patched HOTV with amblyopic patients and Bangerter normals. BMC Ophthalmol. 2017 Dec 4;17(1):232. doi: 10.1186/s12886-017-0624-y.
- Background: PubMed 23360915Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.
- Background: PubMed 23565714Arnold RW, Davis B, Arnold LE, Rowe KS, Davis JM. Calibration and validation of nine objective vision screeners with contact lens-induced anisometropia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):184-90. doi: 10.3928/01913913-20130402-02. Epub 2013 Apr 9.
- Background: PubMed 30160295Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29.
- Background: PubMed 25000209Kirk S, Armitage MD, Dunn S, Arnold RW. Calibration and validation of the 2WIN photoscreener compared to the PlusoptiX S12 and the SPOT. J Pediatr Ophthalmol Strabismus. 2014 Sep-Oct;51(5):289-92. doi: 10.3928/01913913-20140701-01. Epub 2014 Jul 8.
- Background: PubMed 31077668Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
- Derived from this study: PubMed 31631961Arnold AW, Arnold SL, Sprano JH, Arnold RW. School bus accommodation-relaxing skiascopy. Clin Ophthalmol. 2019 Oct 8;13:1841-1851. doi: 10.2147/OPTH.S219031. eCollection 2019.
- Individual participant dataSharing planned: Yes. de-identified database on-line available
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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 Refractive Errors and Amblyopia, 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 30 Jan 2024. 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 Risk Factor (refractive error and/or strabismus) (time frame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.). 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 NCT03668067, which also lists 7 linked publications.
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 30 Jan 2024.