Engineering Evaluation of an Eye Movement Monitor Device

Engineering Evaluation of an Eye Movement Monitor Device

The objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus.

This engineering evaluation is not an applicable clinical trial. This is a design validation of the mechanism of action of the device to measure eye movement. This is not a clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.

This non-significant risk device evaluation involves obtaining retinal images and eye movement measurements with the Retitrack device for purposes of design verification and validation testing. These measurements are not intended for use in diagnosing, preventing, monitoring, or alleviating a medical condition. This evaluation is not intended to assess biomedical or other health-related outcomes.

The evaluation involves the voluntary participation of up to 40 healthy adults who participate in a single device testing visit conducted over one or two days. The Retitrack is used to assess the alignment of the eye for image capture, the ability to measure and analyze eye movements for fixational and visually guided saccadic responses, and the usability of the device.

Inclusion Criteria:

• History of good health
• Willing to participate in testing over 1 to 2 days with rest periods
• Willing to participate in device testing involving viewing visual targets, moving eyes as directed, and holding head steady
• Willing to have retinal images recorded for eye movement measurements

Exclusion Criteria:

• Refractive correction with glasses or contact lenses of more than 12 diopters of myopia or 4 diopters of hyperopia in either eye
• Active eye disease in either eye
• History of ocular surgery or ocular trauma in either eye within the past three months
• Ocular conditions in either eye that could interfere with obtaining a clear retinal image
• Ocular conditions in either eye that could affect the ability to view a stimulus or limit eye movement
• Neurological conditions that could affect eye movements