Strabismic AmblyopiaNCT04195711
Comparative Validation of "Blinq" and "2WIN" Vision Screeners
An observational study of Strabismic Amblyopia and Refractive Amblyopia, run by Alaska Blind Child Discovery at 1 site in United States.
Trial summary
After 28 years of development, the binocular birefringence screener ("blinq," "Rebion") was commercially released. It need to be validated with AAPOS (American Association for Pediatric Ophthalmology and Strabismus) criteria in part because the next Uniform Standards document is pending. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Strabismic Amblyopia, Refractive Amblyopia, Strabismus
- What is being tested?
- objective pediatric vision screen, "blinq,"
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 26 Nov 2019
- 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 year to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Patients in pediatric eye and adult strabismus practice
Who may be able to join
- Children in Pediatric Ophthalmology Practice Adult strabismus patients
- -
Who cannot join
- patients with enucleations patients with eviscerations patients with exenterations
- -
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: Comparative Validation of the Birefringent Amblyopia Screener With Isolated Small-angle Strabismus
After 28 years of development, the binocular birefringence screener ("blinq," "Rebion") was commercially released. It need to be validated with AAPOS (American Association for Pediatric Ophthalmology and Strabismus) criteria in part because the next Uniform Standards document is pending.
Adult and children pediatric and strabismus patients were screened with blinq and "2WIN" photoscreener with "CR" corneal reflex alignment test and then compared to confirmatory exam with age-appropriate determination of binocular status.
Read the detailed description
As a part of a new or follow-up comprehensive eye examinations, patients were screened with two novel objective devices according to AAPOS Uniform guidelines. Following the refractive, alignment and sensory testing, cycloplegic refraction was performed 30 or more minutes after cyclopentolate 1% drops. In cooperative patients, sensory tests including Worth 4-dot, Stereo Fly and "PDI Check" were performed to characterize binocularity. For younger patients, binocular function was estimated by Bruckner Test, 4- base out prism cover and the CR corneal reflex component of "2WIN" photoscreener ("Adaptica," Padova Italy).
Each patient was screened with a recently commercially released blinq screener according to manufacturer's recommendations. If an initial interpretation of "pass" or "refer" was not achieved, then repeat efforts with "timed out" or "inconclusive" were accomplished and results evaluated as if a "refer." An example of blinq birefringent screening is shown in [video].
Patients were screened with the binocular infrared autorefractor "2WIN" according to manufacturer guidelines. Refractive referral criteria were not age-stratified.
The "Rebion blinq" is a unique screening method and therefore we sought to provide appropriate validation. In addition to non-age stratified AAPOS 2003 Uniform guidelines, we collected all cases characterized by constant or persistent strabismus whether large- or small angle employing cover test, 4 base out test, Bruckner Test and "2WIN CR" function. We did not employ any method of retinal videographic analysis of fixation instability.
De-identified patient data recorded for sharing on study website.
- Conditions
- Strabismic Amblyopia, Refractive Amblyopia, Strabismus
- Being tested
- objective pediatric vision screen, "blinq,"
- Keywords
- vision screening, amblyopia
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
objective pediatric vision screen, "blinq,"Diagnostic test
Also called photoscreen, birefringent screen
hand-held birefringent screener for simultaneous foveation
| Study group | Role | What they receive |
|---|---|---|
| blinq screened | Patients screened by new birefringent screener Receives: Diagnostic Test: objective pediatric vision screen, "blinq," |
What is being measured
The primary outcome is the main question the study is designed to answer.
2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence
presence of refractive risk factor (anisometropia >1.5 D, hyperopia>3.5 D, astigmatism ≥1.5 D, myopia 3 D or more) and/or strabismus constant >10 PD
Measured: 1 week
Secondary outcomes (1)
Binocularity
Any defective Sensory (stereopsis > 200 sec arc, ocular Worth 4-Dot suppression distance and/or near) and/or objective ocular alignment (positive Bruckner Test, positive 4 prism base out test, or "2WIN" "CR" corneal reflex alignment > 10 PD)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start18 Nov 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Strabismic 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
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195711
- Sponsor's protocol ID
- ABCD blinq 2WIN
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 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 via website
Publications
Birch EE, Subramanian V, Weakley DR. Fixation instability in anisometropic children with reduced stereopsis. J AAPOS. 2013 Jun;17(3):287-90. doi: 10.1016/j.jaapos.2013.03.011.
PubMed 23791411Gramatikov BI, Irsch K, Wu YK, Guyton DL. New pediatric vision screener, part II: electronics, software, signal processing and validation. Biomed Eng Online. 2016 Feb 4;15:15. doi: 10.1186/s12938-016-0128-7.
PubMed 26847626Arnold 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 RW. Comparative AAPOS Validation of the Birefringent Amblyopia Screener with Isolated Small-Angle Strabismus. Clin Ophthalmol. 2020 Jan 31;14:325-329. doi: 10.2147/OPTH.S242335. eCollection 2020.
PubMed 32099317
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
- Comparative Validation of the Birefringent Amblyopia Screener With Isolated Small-angle Strabismus
- ClinicalTrials.gov ID
- NCT04195711
- Acronym / sponsor ID
- ABCD blinq 2WIN
- Conditions
- Strabismic Amblyopia, Refractive Amblyopia, Strabismus
- Keywords
- vision screening, amblyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 12 Dec 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.
After 28 years of development, the binocular birefringence screener ("blinq," "Rebion") was commercially released. It need to be validated with AAPOS (American Association for Pediatric Ophthalmology and Strabismus) criteria in part because the next Uniform Standards document is pending.
Adult and children pediatric and strabismus patients were screened with blinq and "2WIN" photoscreener with "CR" corneal reflex alignment test and then compared to confirmatory exam with age-appropriate determination of binocular status.
Detailed description
As a part of a new or follow-up comprehensive eye examinations, patients were screened with two novel objective devices according to AAPOS Uniform guidelines. Following the refractive, alignment and sensory testing, cycloplegic refraction was performed 30 or more minutes after cyclopentolate 1% drops. In cooperative patients, sensory tests including Worth 4-dot, Stereo Fly and "PDI Check" were performed to characterize binocularity. For younger patients, binocular function was estimated by Bruckner Test, 4- base out prism cover and the CR corneal reflex component of "2WIN" photoscreener ("Adaptica," Padova Italy).
Each patient was screened with a recently commercially released blinq screener according to manufacturer's recommendations. If an initial interpretation of "pass" or "refer" was not achieved, then repeat efforts with "timed out" or "inconclusive" were accomplished and results evaluated as if a "refer." An example of blinq birefringent screening is shown in [video].
Patients were screened with the binocular infrared autorefractor "2WIN" according to manufacturer guidelines. Refractive referral criteria were not age-stratified.
The "Rebion blinq" is a unique screening method and therefore we sought to provide appropriate validation. In addition to non-age stratified AAPOS 2003 Uniform guidelines, we collected all cases characterized by constant or persistent strabismus whether large- or small angle employing cover test, 4 base out test, Bruckner Test and "2WIN CR" function. We did not employ any method of retinal videographic analysis of fixation instability.
De-identified patient data recorded for sharing on study website.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blinq screened | – | Diagnostic Test: objective pediatric vision screen, "blinq,"Patients screened by new birefringent screener |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in pediatric eye and adult strabismus practice
Key inclusion criteria (2 listed)
- Children in Pediatric Ophthalmology Practice Adult strabismus patients
- -
Key exclusion criteria (2 listed)
- patients with enucleations patients with eviscerations patients with exenterations
- -
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 |
|---|---|---|
| objective pediatric vision screen, "blinq,"Also: photoscreen, birefringent screenhand-held birefringent screener for simultaneous foveation | Diagnostic test | blinq screened |
Primary outcome
2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence
Time frame: 1 week
presence of refractive risk factor (anisometropia >1.5 D, hyperopia>3.5 D, astigmatism ≥1.5 D, myopia 3 D or more) and/or strabismus constant >10 PD
1 secondary outcome
Binocularity
Time frame: 1 week
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 23791411Birch EE, Subramanian V, Weakley DR. Fixation instability in anisometropic children with reduced stereopsis. J AAPOS. 2013 Jun;17(3):287-90. doi: 10.1016/j.jaapos.2013.03.011.
- Background: PubMed 26847626Gramatikov BI, Irsch K, Wu YK, Guyton DL. New pediatric vision screener, part II: electronics, software, signal processing and validation. Biomed Eng Online. 2016 Feb 4;15:15. doi: 10.1186/s12938-016-0128-7.
- 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.
- Background: PubMed 32099317Arnold RW. Comparative AAPOS Validation of the Birefringent Amblyopia Screener with Isolated Small-Angle Strabismus. Clin Ophthalmol. 2020 Jan 31;14:325-329. doi: 10.2147/OPTH.S242335. eCollection 2020.
- Individual participant dataSharing planned: Yes. de-identified via 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Strabismic Amblyopia and Refractive 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 2 inclusion and 2 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?
2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence (time frame: 1 week). 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 NCT04195711, which also lists 4 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 19 Oct 2020.