AmblyopiaNCT02536963
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
An observational study of Amblyopia and Strabismus, run by Rebiscan, Inc. at 1 site in United States.
Trial summary
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest… Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Pediatric Vision Scanning device and Reference examination
- Type of treatment
- Medical device
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-5 who present themselves to the pediatric clinic for well-visits.
Who may be able to join
- Between the ages of 8-10, presenting for a well-visit (for enrollment for first primary outcome)
- Between the ages of 2-5, presenting for a well-visit (for enrollment for second primary outcome)
Who cannot join
- No developmental delay or cognitive deficit
- No visually obvious ocular conditions that would warrant specialist referral
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Permanente Group
La Palma, California, 90623
About this study
Official title: Amblyopia and Strabismus Testing in Pediatrics
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children.
The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.
Read the detailed description
After demonstrating feasibility, we will recruit 300 clinical trial participants during previously scheduled visits at two Kaiser Permanente of Southern California (KPSC) pediatric clinics. We will also send letters and placed phone calls to parents of eligible children who lived in cities proximal to the two clinics. Children will be considered eligible if age is ≥ 2 years old, less than 6 years old; have never visited an ophthalmologist (as this could indicate a pre-existing eye condition and/or introduce biased eye exam results if the physician had seen the patient before), are an active Kaiser Permanente member, and do not have a cognitive and/or developmental disability (ICD-10 codes Z82.79 and F84.0).
Interested participants will either visit an on-site ophthalmology clinic immediately following their pediatric visit or make a future appointment at one of two KPSC ophthalmology clinics. All study activities will be completed during one appointment. Research staff describe the study to parents and obtain informed consent, collected parent-reported demographic data about each participant, screen each participant using the PVS, and documented PVS results, test acquisition time, and participant cooperation. Testing will be performed in a dimly lit room with the child seated on a chair or parents lap. Per manufacturer recommendations, a background calibration measurement is first obtained off of the face with closed eyes. Then the child is asked to open both eyes and fixate on the smiley face target within the device while the binocular retinal polarization scan is performed. PVS results will be interpreted as either "pass" or "refer" based on manufacturer recommendations. Acquisition time is defined as time from when the research staff picked up the PVS to when the result is generated, and cooperation is defined as "excellent" or "fair" based on staff discretion (e.g., a patient who listens to instructions and completes the exam on the first try would be "excellent," whereas a patient who moves his/her head around during testing would be "fair"). A pediatric ophthalmologist masked to the PVS result then performs a gold standard eye examination. Possible gold standard examination results were "normal", "normal with risk factors" (Table Amblyopia Risk Factors - see protocol), "suspected binocular vision deficit," "suspected amblyopia," "amblyopia, "strabismus" and "amblyopia and strabismus." (Diagnostic Categories Rubric - see protocol). Results were mutually exclusive. To compare the PVS results to the gold standard eye examination among the 300 children eligible for analysis, we will perform a validation characteristics analysis with a 95% confidence interval (CI).
- Conditions
- Amblyopia, Strabismus
- Being tested
- Pediatric Vision Scanning device, Reference examination
- 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 Scanning deviceDevice
The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.
Reference examinationOther
Also called Gold-standard eye exam
Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
| Study group | Role | What they receive |
|---|---|---|
| PVS Screening and reference examination | All enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit. They will then receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results. Receives: Device: Pediatric Vision Scanning device; Other: Reference examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device
Screening device will provide a binocularity score from 0-100. Scores ≥60 indicate "normal" exams, while scores <60 are "refers" for amblyopia and strabismus. Device results will be compared to the gold standard eye examination performed by a pediatric ophthalmologist.
Measured: Screenings will be performed during a normally scheduled well-child visit, which lasts on average 20 minutes. Eye examinations for "refer" screenings will occur immediately after well-child visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebiscan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Foundation Research Institute
- Responsible party
- Sponsor
- Investigators
- Ashish Mehta, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536963
- Sponsor's protocol ID
- R44EY025926
- Status last verified
- Jun 2020
- First submitted
- 24 Aug 2015
- Last updated
- 1 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will not be shared; cumulative results from the study may be presented in research journals and/or society conferences.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amblyopia and Strabismus Testing in Pediatrics
- ClinicalTrials.gov ID
- NCT02536963
- Acronym / sponsor ID
- R44EY025926
- Conditions
- Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Rebiscan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Foundation Research Institute
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Posted 1 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children.
The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.
Detailed description
After demonstrating feasibility, we will recruit 300 clinical trial participants during previously scheduled visits at two Kaiser Permanente of Southern California (KPSC) pediatric clinics. We will also send letters and placed phone calls to parents of eligible children who lived in cities proximal to the two clinics. Children will be considered eligible if age is ≥ 2 years old, less than 6 years old; have never visited an ophthalmologist (as this could indicate a pre-existing eye condition and/or introduce biased eye exam results if the physician had seen the patient before), are an active Kaiser Permanente member, and do not have a cognitive and/or developmental disability (ICD-10 codes Z82.79 and F84.0).
Interested participants will either visit an on-site ophthalmology clinic immediately following their pediatric visit or make a future appointment at one of two KPSC ophthalmology clinics. All study activities will be completed during one appointment. Research staff describe the study to parents and obtain informed consent, collected parent-reported demographic data about each participant, screen each participant using the PVS, and documented PVS results, test acquisition time, and participant cooperation. Testing will be performed in a dimly lit room with the child seated on a chair or parents lap. Per manufacturer recommendations, a background calibration measurement is first obtained off of the face with closed eyes. Then the child is asked to open both eyes and fixate on the smiley face target within the device while the binocular retinal polarization scan is performed. PVS results will be interpreted as either "pass" or "refer" based on manufacturer recommendations. Acquisition time is defined as time from when the research staff picked up the PVS to when the result is generated, and cooperation is defined as "excellent" or "fair" based on staff discretion (e.g., a patient who listens to instructions and completes the exam on the first try would be "excellent," whereas a patient who moves his/her head around during testing would be "fair"). A pediatric ophthalmologist masked to the PVS result then performs a gold standard eye examination. Possible gold standard examination results were "normal", "normal with risk factors" (Table Amblyopia Risk Factors - see protocol), "suspected binocular vision deficit," "suspected amblyopia," "amblyopia, "strabismus" and "amblyopia and strabismus." (Diagnostic Categories Rubric - see protocol). Results were mutually exclusive. To compare the PVS results to the gold standard eye examination among the 300 children eligible for analysis, we will perform a validation characteristics analysis with a 95% confidence interval (CI).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVS Screening and reference examination | – | Device: Pediatric Vision Scanning device, Other: Reference examinationAll enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit. They will then receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-5 who present themselves to the pediatric clinic for well-visits.
Key inclusion criteria (2 listed)
- Between the ages of 8-10, presenting for a well-visit (for enrollment for first primary outcome)
- Between the ages of 2-5, presenting for a well-visit (for enrollment for second primary outcome)
Key exclusion criteria (2 listed)
- No developmental delay or cognitive deficit
- No visually obvious ocular conditions that would warrant specialist referral
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 Scanning deviceThe Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye. | Device | PVS Screening and reference examination |
| Reference examinationAlso: Gold-standard eye examReference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist. | Other | PVS Screening and reference examination |
Primary outcome
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device
Time frame: Screenings will be performed during a normally scheduled well-child visit, which lasts on average 20 minutes. Eye examinations for "refer" screenings will occur immediately after well-child visit.
Screening device will provide a binocularity score from 0-100. Scores ≥60 indicate "normal" exams, while scores <60 are "refers" for amblyopia and strabismus. Device results will be compared to the gold standard eye examination performed by a pediatric ophthalmologist.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; cumulative results from the study may be presented in research journals and/or society conferences.
Related trials for Amblyopia
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Non-invasive Induction of Metaplasticity for Amblyopia
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Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
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Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
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Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults
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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.
Ashish Mehta, MD principal investigator
Kaiser Permanente
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 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 1 Jul 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?
Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device (time frame: Screenings will be performed during a normally scheduled well-child visit, which lasts on average 20 minutes. Eye examinations for "refer" screenings will occur immediately after well-child visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2020.