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 US are undetected and untreated until after it is too late, making it the leading cause of preventable vision loss. REBIScan has developed retinal birefringence scanning (RBS) into a commercial product, the RBS-based Pediatric Vision Scanner (PVS), which detects amblyopia and strabismus with 94% accuracy, compared with 69% accuracy of non-RBS methods. However RBS-based scanning faces challenges – including the need for moving parts and the presence of significant background noise necessitating background measurements – that may limit widespread commercial acceptance of this technology. REBIScan has now conceptualized a new approach toward assessment of retinal birefringence that we call retinal birefringence imaging (RBI). Like RBS, this approach measures the polarization signature produced by the Henle nerve fibers at the center of fixation of the retina, thus objectively detecting ocular fixation, but it can be implemented with no moving parts and without the need for background measurements. Imaging will be obtained in a fraction of a second (vs. 2.5 seconds of scanning required for an accurate RBS measurement.) The design will also allow for incorporation of a photoscreening channel for assessment of refractive error in synchrony with detection of amblyopia and strabismus. In this Phase I study, we will test the hypothesis that RBS performance can be replicated and enhanced using retinal birefringence imaging (RBI). The existing RBS architecture and software will be modified to implement the concept and construct a prototype. The enhanced device will then be tested in an artificial patient consisting of two yoked model eyes. Successful execution of project milestones will lead to pilot studies followed by clinical trials, which, if successful, will culminate in commercial development of an RBI device. This handheld machine will serve as an objective tool with a high level of accuracy for detecting amblyopia and strabismus within primary care settings staffed with lay screeners. The transition from a scanning-based approach to an imaging-based approach for pediatric vision screening may ultimately allow for implementation of RBI as a smartphone-based mobile application, further improving patient access to expert medical diagnosis.

Public Health Relevance Statement:
Project Narrative REBIScan proposes to produce a handheld, no-moving-parts device for providing quick, noninvasive detection of amblyopia and strabismus, the leading causes of preventable vision loss in children in the United States. Current methods, including REBIScan's own Pediatric Vision Scanner, require complex scanning equipment that is prone to confounding error produced by ambient light or short attention spans. The image-based method of this proposal will eliminate moving parts and allow for future implementation in a smartphone application format, improving access to this technology for patients and providers.

Project Terms:
abstracting; Adoption; Age; Amblyopia; Anisometropia; Architecture; Attention; Award; base; Birefringence; Blindness; Cellular Phone; Child; Childhood; Clinical; Clinical Trials; Code; Complex; Computer software; deprivation; design; Detection; Development; Devices; Diagnosis; Early Diagnosis; Ensure; Equipment; experience; Eye; Face; Fund Raising; Future; Goals; handheld equipment; Image; Imaging Device; Improve Access; improved; International; Laboratories; Lead; Light; Marketing; Measurement; Measures; Medical; meetings; meter; Methodology; Methods; mobile application; Modeling; Modification; National Eye Institute; neglect; Nerve Fibers; Noise; novel strategies; Ocular Fixation; Ocular Prosthesis; Optics; Outcome; Patients; Performance; Phase; phase 1 study; Pilot Projects; point of care; primary care setting; programs; prototype; Provider; Refractive Errors; research clinical testing; Retina; Retinal; Safety; safety testing; sample fixation; Scanning; Scientist; screening; Small Business Innovation Research Grant; sound; Strabismus; Technology; technology validation; Testing; Time; tool; United States; Vision; Vision Disorders; Vision Screening; Writing

Amblyopia is vision loss caused by suppression of a structurally normal eye due to strabismus, asymmetric refraction (anisometropia), or deprivation. Treatment becomes challenging if not caught by age 7, but half of all patients in the US are undetected and untreated until after it is too late, making it the leading cause of preventable vision loss. Rebion has developed retinal birefringence scanning (RBS) into a commercial product, the RBS-based Pediatric Vision Scanner (PVS), which detects amblyopia and strabismus with 94% accuracy, compared with 69% accuracy of non-RBS methods. However RBS-based scanning faces challenges ? including the need for costly moving parts and the presence of significant background noise necessitating background measurements ? that may limit widespread commercial acceptance of this technology. With prior Phase I NEI funding (EY 027633) Rebion has successfully built a new approach toward assessment of retinal birefringence that we call retinal birefringence imaging (RBI). Like RBS, this approach measures the polarization signature produced by the Henle nerve fibers at the center of fixation of the retina, thus objectively detecting ocular fixation, but it can be implemented with no moving parts and without the need for background measurements. Imaging are obtained in a fraction of a second (vs. 2.5 seconds of scanning required for an accurate RBS measurement.) The design also allows for future incorporation of a photoscreening channel for assessment of refractive error in synchrony with detection of amblyopia and strabismus. In this Phase II study, we will test the hypothesis that the performance of the RBI device can match the sensitivity, specificity, and accuracy of the commercially available PVS device in a large-scale clinical trial. The RBI device built with Phase I funding will be deployed with the Retina Foundation of the Southwest, and tested in both the enriched population of eye care clinics, as well as un-enriched populations of primary care clinics. The disease prevalence of primary care clinics will more closely mimic the disease prevalence of the general population, while the disease prevalence of eye clinics will allow the study to carry statistical significance in the most cost-effective use of NIH funds. Successful execution of project milestones will lead to an immediate transition to regulatory clearance with FDA and manufacturing with Rebion's contract manufacturer. This advance will greatly reduce expenses and complexities related to pediatric vision screening.

Thesaurus Terms:
Adoption; Age; Aged; Amblyopia; Anisometropia; Attention; Base; Betula Genus; Birefringence; Blindness; Care Providers; Caring; Child; Childhood; Clinic; Clinical Paths; Clinical Trials; Complex; Computerized Data Processing; Contracts; Cost; Cost Effective; Custom; Data; Data Collection; Deprivation; Design; Detection; Devices; Diagnosis; Disease; Doctor Of Philosophy; Early Diagnosis; Enrollment; Equipment; Eye; Face; Foundations; Funding; Future; General Population; Goals; Image; Image Processing; Imaging Device; Imaging Modality; Improved; Individual; Laboratories; Light; Manufacturer Name; Measurement; Measures; Medical Specialties; Methodology; Methods; Millisecond; National Eye Institute; Nerve Fibers; Noise; Novel Strategies; Ocular Fixation; Ophthalmic Examination And Evaluation; Ophthalmology; Outcome; Output; Participant; Patients; Performance; Phase; Phase 2 Study; Point Of Care; Population; Positioning Attribute; Prevalence; Primary Care Setting; Primary Health Care; Programs; Prototype; Publishing; Refractive Errors; Reproducibility; Research Clinical Testing; Retina; Retinal; Retinal Imaging; Sample Fixation; Savings; Scanning; Screening; Sensitivity And Specificity; Sensor; Signal Transduction; Sound; Specific Qualifier Value; Speed; Strabismus; Study Population; System; Technology; Test Result; Testing; Time; United States; United States National Institutes Of Health; Vision; Vision Disorders; Vision Screening; Young Adult;