SBIR-STTR Award

?In this project, we propose to develop and demonstrate feasibility of a smartphone-based mobile eye alignment application (MEAA) for use by lay people as well as eye-care professionals to screen for strabismus. Strabismus develops in an estimated 3-8% of the U.S. population, and is a leading risk factor for amblyopia in young children. Early detection and treatment are critical to prevention of permanent vision losses, yet only 40% of U.S. children under age 6 reportedly receive vision screening. In the elderly and in head trauma populations where the prevalence is highest, untreated strabismus can result in postural instability, leading to a significantly greater risk of devastating falls. However, signifcant barriers of cost and availability of trained examiners limit access to strabismus screening for at-risk populations, especially in under-served rural and low-income areas and elder care facilities. The novel MEAA, currently capable of resolving 3 prism diopter differences in alignment (equivalent to 1.7° angle), provides the first image-based tool for eye alignment testing by lay persons without reliance on a costly device. We propose to further develop the MEAA to enable accurate detection of strabismus in a wide variety of subjects, including individuals wearing corrective lenses, with vertical strabismus, with non-standard iris diameter, and subjects who exhibit anomalous head posture or are unable to maintain fixation. Through our clinical collaborations we will evaluate MEAA performance relative to standard test methodology in targeted populations likely to contain subjects who are difficult to accurately measure, including both young children and head trauma patients. We will also report initial estimates of MEAA sensitivity and specificity in these targeted populations. At the conclusion of the Phase I project we will have demonstrated feasibility of the novel mobile eye alignment application, showing accuracy, precision, and reproducibility comparable to or exceeding costly tests now employed in strabismus screening programs outside ophthalmology practices. The wide availability of this low cost, smartphone-based strabismus screening application could make possible a paradigm shift in cost-benefit calculations and increase awareness for vision screening programs, resulting in greater access to treatment for strabismus-affected individuals. Once the sensitivity and specificity for the MEEA meet or exceed those of current methods in populations representative of vision screening, we will prepare for clinical trials and FDA/IDE submission in Phase II.

Public Health Relevance Statement:


Public Health Relevance:
Strabismus (crossed eyes) affects an estimated 3-8% of the U.S. population and is a leading risk factor for vision degradation in children due to amblyopia. In the elderly and in head trauma victims, strabismus can lead to postural instability and is associated with increased risk of potentially incapacitating injuries. Early diagnosis and treatment are key to mitigating these risk factors and preventing serious vision loss or injury, bu public health efforts to screen for strabismus have been hampered by significant barriers of cost and the need for highly trained examiners. A recent study reported that only 40% of children in the U.S. receive vision screening by age 6. The overall goal of the proposed Phase I project is to develop an automated, cost-effective, smart phone-based strabismus screening application that can be used by lay people as well as clinicians, thereby enabling strabismus screening to become widely available to under- served, at-risk populations.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Brain Disorders; Clinical Research; Comparative Effectiveness Research; Congenital Structural Anomalies; Eye Disease and Disorders of Vision; Health Services; Neurosciences; Pediatric; Prevention; Rural Health

Project Terms:
3 year old; Affect; Age; Amblyopia; Area; Awareness; base; Biomedical Engineering; Blindness; Brain Injuries; Caliber; Caring; Cellular Phone; Child; Childhood; Clinical; clinical decision-making; Clinical Investigator; Clinical Trials; Collaborations; college; Color; commercialization; Cornea; cost; cost effective; Costs and Benefits; Craniocerebral Trauma; Detection; Development; Devices; Early Diagnosis; Early treatment; Elderly; Environment; Equilibrium; Esotropia; Evaluation; Exhibits; Eye; fall risk; falls; gang; Glosso-Sterandryl; Goals; Head; Health Resources; Health Services Accessibility; Hospitals; Image; improved; Individual; Injury; Institution; Iris (Eye); Lead; lens; Light; Low income; Marketing; Measurement; Measures; Medical; meetings; Methodology; Methods; Neighborhoods; New England; novel; Ophthalmology; Optometry; patient population; Patients; Performance; performance tests; Persons; Phase; Population; Populations at Risk; portability; Posture; Prevalence; prevent; Prevention; programs; prototype; public health medicine (field); public health relevance; Pupil; Rehabilitation therapy; Relative (related person); Reporting; Reproducibility; research clinical testing; Research Institute; Research Personnel; Risk; Risk Factors; Rural; rural area; sample fixation; screening; Sensitivity and Specificity; Shapes; software development; Software Engineering; Specialist; Strabismus; stroke; Structure; System; Target Populations; Testing; tool; Training; Trauma patient; tv watching; Vision; Vision Screening; Visual impairment

In this project we propose to complete development and performance evaluation of a smartphone-based mobile medical application (EyeTurn) for use by eye-care professionals and lay people to screen for strabismus (eye misalignment). Strabismus develops in an estimated 3-8% of the U.S. population and is a leading risk factor for amblyopia in young children. Early detection and treatment are critical to prevention of permanent vision losses, yet only 40% of U.S. children under age 6 reportedly receive vision screening. In the elderly and in head trauma populations where the prevalence is highest, untreated strabismus can result in postural instability, leading to a significantly greater risk of devastating falls. However, significant barriers of cost and availability of trained examiners limit access to strabismus screening for at-risk populations, especially in under-served rural and low-income areas and elder care facilities. The novel EyeTurn app provides the first image-based tool for eye alignment testing by lay persons without reliance on a costly device. We propose to further develop the EyeTurn app to improve reliability of automatic eye detection and vertical strabismus measurement, add HIPAA-compliant patient data management, improve the operator interface for cover- uncover testing and for screening/home use, and incorporate modules for user training, patient education, and doctor finding. We will evaluate EyeTurn performance relative to standard test methodology in targeted populations likely to contain subjects who are difficult to accurately measure, including both young children and head trauma or low vision patients. We will also report initial estimates of EyeTurn sensitivity and specificity in a pilot-scale application to pediatric screening. At the conclusion of the Phase II project, we will have demonstrated accuracy, reliability and effective range comparable to or exceeding costly tests now employed in strabismus screening. Bringing this low cost product to wide commercial availability, we could make possible a paradigm shift in cost-benefit calculations for strabismus screening and measurement globally, resulting in greater access to treatment for strabismus-affected individuals. A demonstrated effectiveness for use by vision care professionals will position EyeTurn to apply for FDA pre-market approval and perform clinical trials in support of use by lay people for strabismus screening.

Public Health Relevance Statement:
PROJECT NARRATIVE Strabismus (crossed eyes) affects an estimated 3-8% of the U.S. population and is a leading risk factor for vision degradation in children due to amblyopia. In the elderly and in head trauma victims, strabismus can lead to postural instability and is associated with increased risk of potentially incapacitating injuries. Early diagnosis and treatment are key to mitigating these risk factors and preventing serious vision loss or injury, but public health efforts to screen for strabismus have been hampered by significant barriers of cost and the need for highly trained examiners. A recent study reported that only 40% of children in the U.S. receive vision screening by age 6. The overall goal of the proposed Phase II project is to complete development and clinic-based performance evaluation of an automated, cost-effective, smartphone-based strabismus screening application (EyeTurn) that can be used by lay people as well as clinicians, thereby enabling strabismus screening and measurement to become widely available to under-served, at-risk populations.

Project Terms:
Address; Adopted; Adult; Affect; Age; Algorithms; Amblyopia; Area; base; Blindness; Boston; Caring; Cellular Phone; Child; Childhood; Clinic; Clinical; clinical Diagnosis; Clinical Trials; Color; commercialization; Computer software; Cornea; cost; cost effective; Costs and Benefits; Craniocerebral Trauma; Data; data management; design; Detection; Development; Devices; Doctor of Optometry; Early Diagnosis; Early treatment; Elderly; Esotropia; Evaluation; Eye; falls; Financial compensation; gaze; Goals; Health Insurance Portability and Accountability Act; Health Services Accessibility; Home environment; Hospitals; Image; improved; Incidence; Individual; Injury; invention; Iris; Lead; Legal patent; Light; Long-Term Care for Elderly; Low income; Measurement; Measures; Medical; Methodology; Methods; Motor; novel; Ophthalmologist; Ophthalmology; Optometrist; Patient Education; patient population; Patients; Performance; Persons; Phase; Population; Populations at Risk; Positioning Attribute; posture instability; Preparation; Prevalence; prevent; Prevention; Privatization; product development; programs; Public Health; Pupil; Rehabilitation therapy; Reporting; Research; research clinical testing; Research Institute; response; Risk; Risk Factors; Rural; Scientist; screening; Sensitivity and Specificity; Shapes; software development; Specificity; Strabismus; Structure; Study Subject; success; Suggestion; Target Populations; Technology; Telemedicine; Testing; tool; Training; usability; Use Effectiveness; Vision; Vision Screening; Visual impairment