AmblyopiaNCT01832883
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
An observational study of Amblyopia and Strabismus, run by Rebiscan, Inc. at 1 site in United States.
Trial summary
The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Pediatric Vision Scanner
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jul 2012
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children presenting for ophthalmic exam at eye clinic.
Who may be able to join
- Children aged 3-8 years
- Signed Informed consent by parent or guardian
- Meet all inclusion criteria.
Who cannot join
- Children with a history of developmental delay or cognitive deficit
- Children unable to complete the GSE (including visual acuity testing)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
About this study
Official title: Pediatric Vision Scanner 4 (PVS4)
The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.
- Conditions
- Amblyopia, Strabismus
- Being tested
- Pediatric Vision Scanner
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Vision ScannerDevice
Subject is scanned with a 2.5 second pediatric vision scanner device test.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Structurally normal eye with equal visual acuity and normal stereopsis. Receives: Device: Pediatric Vision Scanner | |
| Referral required | Diagnosed with amblyopia or constant strabismus, categorized based on the GSE.
Amblyopia:
* VA <20/40 and 2 logMAR lines difference in normal eye
* Mild amblyopia (>20/40)
* Moderate amblyopia (20/40 and <20/100)
* Severe amblyopia (≥20/100 or worse)
* Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism.
Strabismus:
* Constant: >2 PD at near and or distance.
* Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position.
Amblyogenic factor categorization:
* 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes.
* 'hypermetropia' (≥3.5 D),
* 'myopia' (≥-4.0 D),
* 'astigmatism' (≥1.5 D).
* 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse. Receives: Device: Pediatric Vision Scanner | |
| Borderline | (no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis. Receives: Device: Pediatric Vision Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocularity score
Measured: Day 1
Secondary outcomes (1)
Presence of amblyopia risk factors
'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes.
'hypermetropia' (≥3.5 D), 'myopia' (≥-4.0 D), 'astigmatism' (≥1.5 D). 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionJul 2012
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebiscan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Sean Donahue, MD, PhD, Principal investigator, Vanderbilt Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832883
- Sponsor's protocol ID
- rebiscan-002
- Status last verified
- Apr 2018
- First submitted
- 5 Oct 2012
- Last updated
- 13 Apr 2018
- Results posted
- No
Publications
Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
PubMed 21642624
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Vision Scanner 4 (PVS4)
- ClinicalTrials.gov ID
- NCT01832883
- Acronym / sponsor ID
- rebiscan-002
- Conditions
- Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Rebiscan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Apr 2013 (estimated)
- 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.
The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | – | Device: Pediatric Vision ScannerStructurally normal eye with equal visual acuity and normal stereopsis. |
| Referral required | – | Device: Pediatric Vision ScannerDiagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: * VA <20/40 and 2 logMAR lines difference in normal eye * Mild amblyopia (>20/40) * Moderate amblyopia (20/40 and <20/100) * Severe amblyopia (≥20/100 or worse) * Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism. Strabismus: * Constant: >2 PD at near and or distance. * Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: * 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes. * 'hypermetropia' (≥3.5 D), * 'myopia' (≥-4.0 D), * 'astigmatism' (≥1.5 D). * 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse. |
| Borderline | – | Device: Pediatric Vision Scanner(no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children presenting for ophthalmic exam at eye clinic.
Key inclusion criteria (3 listed)
- Children aged 3-8 years
- Signed Informed consent by parent or guardian
- Meet all inclusion criteria.
Key exclusion criteria (2 listed)
- Children with a history of developmental delay or cognitive deficit
- Children unable to complete the GSE (including visual acuity testing)
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 |
|---|---|---|
| Pediatric Vision ScannerSubject is scanned with a 2.5 second pediatric vision scanner device test. | Device | Borderline, Normal Controls, Referral required |
Primary outcome
Binocularity score
Time frame: Day 1
1 secondary outcome
Presence of amblyopia risk factors
Time frame: Day 1
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 13 Apr 2018.
- Background: PubMed 21642624Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
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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.
Sean Donahue, MD, PhD principal investigator
Vanderbilt Eye Institute
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 Strabismus, run by Rebiscan, Inc. 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 3 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 13 Apr 2018. 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?
Binocularity score (time frame: Day 1). 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 NCT01832883, 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 13 Apr 2018.