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Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging (RBI)

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ClinicalTrials.gov Identifier: NCT03919708
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Retina Foundation of the Southwest
Information provided by (Responsible Party):
Rebiscan, Inc.

Brief 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).

Condition or disease Intervention/treatment
Amblyopia Strabismus Device: 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


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Group/Cohort Intervention/treatment
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.
Device: Retinal Birefringence Imager
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.
Other Name: RBI

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.
Device: Retinal Birefringence Imager
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.
Other Name: RBI




Primary Outcome Measures :
  1. Presence of amblyopia / strabismus [ Time Frame: 1 single day ]
    Readouts of RBI device will be compared to clinical examination results



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children between the ages of 2-8, with no gender, race, or ethnicity restricted from enrollment.
Criteria

Inclusion Criteria:

  • Children who present to the participating clinics
  • Provide assent
  • Guardian provides informed consent

Exclusion Criteria:

- Developmental delay or cognitive deficit


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919708


Contacts
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Contact: Eileen Birch, PhD 214-363-3911 ext 111 ebirch@retinafoundation.org

Locations
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United States, Texas
Retina Foundation of the Southwest Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Eileen Birch, PhD    214-363-3911    ebirch@retinafoundation.org   
Sponsors and Collaborators
Rebiscan, Inc.
Retina Foundation of the Southwest
Investigators
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Principal Investigator: Eileen Birch, PhD Retina Foundation of the Southwest

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Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT03919708     History of Changes
Other Study ID Numbers: rebiscan_RBI_RFSW
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases