NCT05243277

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

December 8, 2021

Last Update Submit

March 27, 2023

Conditions

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

  • Evolution of oculomotor response to a stimulation generating jumps in vergence demand

    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)

Interventions

There will be four visits. Each visit is associated with a different exposure in terms of level of oculomotor conflict. At each visit, several oculomotor tests will be performed, followed by a comfort questionnaire. The oculomotor tests are subjective tests during which the participant will be asked to fix his/her eyes on one or more targets that can move in space and to indicate the way he/she perceives this/these target(s). Depending on the test, lenses may be inserted between the participant and the target to modify his/her perception. The comfort questionnaire consists to rate on a scale of 1 (not at all) to 5 (very much) the presence of visual symptoms, such as burning, watering or dryness. The participant will then have to perform four different perceptual tasks. His/her level of accommodation (i.e. focus) will be monitored throughout the tasks. Each exposure is followed again by eye tests and a comfort questionnaire.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

February 17, 2022

Study Start

March 16, 2023

Primary Completion

December 16, 2024

Study Completion

December 16, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations