SBIR-STTR Award

The National Children's Eye Care Program has produced a mandate to screen the vision of all children by the age of four within the next ten years. This could dramatically effect the treatment of amblyopia and other child development problems, e.g., reading and learning. Vision anomalies are readily corrected at the infant and early adolescent ages. Thus, instruments are needed to provide the screening data such as: refraction/accommodation and strabismus. AMT Technologies (AMT) has developed an enabling technology, the Ocular Biometer (OB), that provides the wavefront sensing capability as well as refraction/accommodation, strabismus, acuity integrated into one instrument. The OB will be inexpensive, easy to operate by non-medical personnel, have structural integrity and be as compact and portable. It typically requires a minute of "face time" to take measurements and provide results requiring no cycloplegic drugs or medical professional This SBIR proposal Phase I effort is to perform laboratory tests with prototypes of the Ocular Biometer to verify the models and analysis. The result of Phase I will be a comprehensive definition of the Phase II clinical trials. In Phase II extended clinical trials will be perfonned in cooperation with the Jules Stein Eye Institute on the University of Califomia campus in Los Angeles

The ultimate objective is to develop products for vision-screening/diagnosis of preschool children. WaveTec Vision Systems has developed combined wavefront-sensing and eye-tracking technology for unobtrusively and dynamically measuring binocular line-of-sight and refraction, including sphere, cylinder, and axis. Realtime eye tracking is also used to assess fixation and attention. With a binocular open view and targets at different distances, the technology measures vergence and accommodation along with standard vision screening parameters. Automated algorithms process pupil images and make a final vision screening decision with no expert viewer required. Within Phase I, Wavetec demonstrated the technology's feasibility for vision screening via mathematical simulation/analysis, engineering trials on prototypes using artificial eyes and automated computer processing, and successful demonstrations on humans. This Product Development grant will design and build two product prototypes; gather feasibility data on adults and preschool children; and use these data to develop robust algorithms for objective vision screening. This is not clinical research or evaluation per se. The data are necessary for the prototype development. The end goal of Phase II is to objectively/subjectively demonstrate product feasibility in terms of ease-of-use, ability of preschool children to comply with the simple task, accuracy of the refraction/alignment measurements, effectiveness of the automated analysis, and reasonable manufacturing cost estimates.

Project Terms:
amblyopia; bioengineering /biomedical engineering; biomedical equipment development; clinical research; computer simulation; diagnosis design /evaluation; eye coordination disorder; eye disorder diagnosis; eye refractometry; human subject; mathematics; pediatrics; portable biomedical equipment; preschool child (1-5); statistics /biometry; vision tests; visual fixation; visual perception; visual tracking