SBIR-STTR Award

Amblyopia is vision loss caused by neglect of a structurally normal eye due to strabismus, asymmetric refraction (anisometropia), or deprivation. It is irreversible if not treated by age 7, but half of all patients in the U.S. are undetected and untreated until after it is too late, making it the leading cause of preventable vision loss. Rebion (Rebiscan, Inc) has developed retinal birefringence scanning (RBS) into a commercial product, the RBS-based “blinq” device, which detects amblyopia and strabismus with 94% accuracy, compared with 69% accuracy of non-RBS methods. Although blinq effectively screens for strabismus and amblyopia by direct detection of these conditions with very high sensitivity (97%), published “specificity” of the device is closer to 87%. Given the 5% prevalence of amblyopia and strabismus, this means that 2 normal patients could potentially be referred for every treatable case. It is therefore essential that “specificity” of blinq be improved if the device is to be adopted widely. One likely cause of false referrals is corneal birefringence, which can interfere with an RBS test. Unlike retinal birefrigence, corneal birefringence can vary greatly between patients and cause inaccurate RBS results. If corneal birefringence could be neutralized as a factor in RBS, the specificity of the blinq device could likely be improved to equal or exceed the device's 97% sensitivity. Leading researchers at Johns Hopkins University (JHU) have developed a novel, patented approach that incorporates corneal birefringence compensation in an RBS system. This approach can be readily optimized within blinq's current mechanical and electrical design. In this Phase I study, we believe that by collaborating with the JHU research team, we will be able to develop a new device that produces significant advantages over existing technologies, including the commercially available blinq device. Applying JHU's research advancements to the FDA-cleared blinq device will allow rapid commercial adoption of a breakthrough technology for detection of amblyopia. The improved end result is that vision screening in the real world will immediately improve and save thousands of children from unnecessary vision loss. Successful execution of this project will help improve the quality of care and outcomes for thousands of children annually, while simultaneously reducing the costs of care for all.

Public Health Relevance Statement:
Project Narrative Rebion (REBIScan, Inc) has an FDA-cleared device – along with its own unique CPT insurance billing code – that detects amblyopia and strabismus, the leading causes of preventable vision loss in children in the United States. Researchers at Johns Hopkins have developed a breakthrough approach for enhancing accuracy of amblyopia detection that can be readily implemented in to the Rebion device. This collaboration will accelerate the commercial adoption of medical and academic research that can help save vision in tens of thousands of children nationwide.

Project Terms:
2 year old; Adopted; Adoption; Affect; Age; Amblyopia; Anisometropia; base; Birefringence; Blindness; care costs; care outcomes; Caring; Child; Childhood; Code; Collaborations; Computer Models; Cornea; Data; Databases; deprivation; design; Detection; Device Designs; Devices; digital; Disease; Early Diagnosis; Evaluation; Eye; Eye diseases; Financial compensation; Funding; Generations; Hand; Human; improved; innovation; Insurance; Intervention; Laboratories; Lazy Eyes; Left; Legal patent; Light; liquid crystal; mathematical model; Measures; Mechanics; Medical; Methods; Modeling; neglect; Nerve Fibers; new technology; Noise; novel; Only Child; operation; Optics; Outcome; Output; Patients; Pattern; Performance; Phase; phase 1 study; polarized light; Population; Prevalence; Privatization; Publishing; Pupil; Quality of Care; Reproducibility; Research; Research Personnel; Retina; Risk Factors; Running; sample fixation; Scanning; Scientist; screening; Signal Transduction; Source; Specialist; Specificity; stem; Strabismus; Structure; Subtraction Technique; System; Techniques; Technology; Testing; United States; Universities; Vision; Vision Disorders; Vision Screening; Work