Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm (ALGO-HMD)

March 27, 2023 updated by: Direction Centrale du Service de Santé des Armées

Operational military personnel are increasingly using virtual or augmented reality headsets in the field or in training. However, these devices cause a conflict between accommodation (focus to see clearly) and vergence (alignment of both eyes on the object being viewed) that can be a source of visual fatigue and altered visual and perceptual abilities. Although techniques exist to limit this conflict for screen-based stimuli, the use of helmet visuals (or immersive headsets) adds technological complexity. Indeed, since accommodation on the screen of the helmet visual is impossible (i.e., distance too small) for the human visual system, lenses are used to virtually shift the image (referred to as a collimated image) so that accommodation can occur much further away. However, this material configuration also modifies the vergence, thus causing a conflict between accommodation and additional vergence that persists regardless of the attenuation technique used.

In this study, the investigator proposed to modify the image display to take into account the technical features of the helmet to correct this techno-dependent conflict. This study is aimed at determining whether the setting recommended by the algorithm developed by the investigator limits visual fatigue better than the conventional setting recommended by manufacturers or a subjective setting controlled by the user.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brétigny-sur-Orge, France, 91223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of healthy subjectfs with no history of visual disorders.

Description

Inclusion Criteria:

  • Age over 18
  • Non-presbyopic
  • Stereoscopic acuity ≤ 60 min of arc

Exclusion Criteria:

  • Accommodative insufficiency (APP ≤ 13-"age"/4, in diopters)
  • Accommodative inertia (+ and - block in binocular)
  • Compensation by orthokeratology
  • Present or past binocular pathology: strabismus or amblyopia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of oculomotor response to a stimulation generating jumps in vergence demand
Time Frame: Until the end of the study (20 months)
Oculomotor response (accommodation and vergence) will be measured continuously via a single objective system (PowerRef 3) at each visit.
Until the end of the study (20 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Anticipated)

December 16, 2024

Study Completion (Anticipated)

December 16, 2024

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PBMD04
  • 2021-A02286-35 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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