AmblyopiaRBINCT03919708
Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging
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 accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager). Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Retinal Birefringence Imager
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 31 May 2023
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between the ages of 2-8, with no gender, race, or ethnicity restricted from enrollment.
Who may be able to join
- Children who present to the participating clinics
- Provide assent
- Guardian provides informed consent
Who cannot join
- Developmental delay or cognitive deficit
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Foundation of the Southwest
Dallas, Texas, 75231
About this study
Official title: Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening
The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).
Read the detailed description
Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.
The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment
- Conditions
- Amblyopia, Strabismus
- Being tested
- Retinal Birefringence Imager
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Birefringence ImagerDevice
Also called RBI
Device is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus.
| Study group | Role | What they receive |
|---|---|---|
| Enriched Population | Children between the ages of 2-8 who present to an eye clinic. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans and exam should be performed within a single visit. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes. Receives: Device: Retinal Birefringence Imager | |
| Unenriched Population | Children between the ages of 2-8 who present to a general pediatric clinic, with no history of eye disorders or amblyopia. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans will be performed at a single visit, but the exam may require a follow up visit, depending on the availability of a pediatric ophthalmologist at the clinic at the time of study enrollment. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes. Receives: Device: Retinal Birefringence Imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of amblyopia / strabismus
Readouts of RBI device will be compared to clinical examination results
Measured: 1 single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start4 Feb 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Funding expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebiscan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Retina Foundation of the Southwest
- Responsible party
- Sponsor
- Investigators
- Eileen Birch, PhD, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919708
- Sponsor's protocol ID
- rebiscan_RBI_RFSW
- Acronym
- RBI
- Status last verified
- Nov 2023
- First submitted
- 16 Apr 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening
- ClinicalTrials.gov ID
- NCT03919708
- Acronym / sponsor ID
- RBI / rebiscan_RBI_RFSW
- Conditions
- Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rebiscan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Retina Foundation of the Southwest
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 Apr 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.
The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).
Detailed description
Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.
The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched Population | – | Device: Retinal Birefringence ImagerChildren between the ages of 2-8 who present to an eye clinic. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans and exam should be performed within a single visit. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes. |
| Unenriched Population | – | Device: Retinal Birefringence ImagerChildren between the ages of 2-8 who present to a general pediatric clinic, with no history of eye disorders or amblyopia. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans will be performed at a single visit, but the exam may require a follow up visit, depending on the availability of a pediatric ophthalmologist at the clinic at the time of study enrollment. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between the ages of 2-8, with no gender, race, or ethnicity restricted from enrollment.
Key inclusion criteria (3 listed)
- Children who present to the participating clinics
- Provide assent
- Guardian provides informed consent
Key exclusion criteria (1 listed)
- Developmental delay or cognitive deficit
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 |
|---|---|---|
| Retinal Birefringence ImagerAlso: RBIDevice is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus. | Device | Enriched Population, Unenriched Population |
Primary outcome
Presence of amblyopia / strabismus
Time frame: 1 single day
Readouts of RBI device will be compared to clinical examination results
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Eileen Birch, PhD principal investigator
Retina Foundation of the Southwest
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 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presence of amblyopia / strabismus (time frame: 1 single day). 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 18 Nov 2023.