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Engineering Evaluation of an Eye Movement Monitor Device

Healthy Clinical Trial

Official title:
Engineering Evaluation of an Eye Movement Monitor Device

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05222022
Study type Interventional
Source C. Light Technologies, Inc.
Contact
Status Completed
Phase N/A
Start date February 18, 2022
Completion date October 10, 2023
View Details
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