Engineering Evaluation of an Eye Movement Monitor Device

NCT05222022 | Completed FDA Device

• 1 other identifier: CLRT-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Eye movement measurement

Outcome Measures

Primary Outcomes (4)

• Device measurement of involuntary fixational microsaccade amplitude

  Microsaccade amplitude (in degrees)

  1 day (Single timepoint)

• Device measurement of involuntary fixational microsaccade velocity

  Microsaccade velocity (in degrees/second)

  1 day (Single timepoint)

• Device measurement of visually guided horizontal saccade amplitude

  Horizontal saccade amplitude (in degrees)

  1 day (Single timepoint)

• Device measurement of visually guided horizontal saccade velocity

  Horizontal saccade velocity (in degrees/second)

  1 day (Single timepoint)

Study Arms (1)

Design validation of mechanism of action of an eye movement measurement device

EXPERIMENTAL

Participants have retinal images captured with the Retitrack device to measure eye movements. The eye movement measurements are intended to validate the mechanism of action of the device.

Device: Retitrack

Interventions

Retitrack DEVICE

Retitrack device measures and analyzes eye movement

Design validation of mechanism of action of an eye movement measurement device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. Light Technologies, Inc.: lead

Study Sites (1)

Blur Product Development

Cary, North Carolina, 27513, United States

Location

Study Officials

• Jacqueline Theis, OD

  Concussion Care Centre of Virginia, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects participated in a design validation to evaluate the mechanism of action of the device to measure eye movement. This is not an applicable clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 3, 2022
• Study Start: February 18, 2022
• Primary Completion: May 31, 2023
• Study Completion: October 10, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)