ClinicalTrials.gg
Status unknownNCT05243277ALGO-HMDUpdated Mar 28, 2023

Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm

An observational study in Visual Fatigue, sponsored by Direction Centrale du Service de Santé des Armées. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Visual Fatigue

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Keywords

  • virtual reality
03

In context

Asthenopia

67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.

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Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • OtherOculomotor tests

    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.

06

What researchers measure

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.

    Time frame: Until the end of the study (20 months)

07

Study locations

1 of 1 sites recruiting
  • Institut de Recherche Biomédicale des Armées
    Brétigny-sur-Orge, 91223, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2021
First posted
Feb 17, 2022
StartActual
Mar 16, 2023
Primary completionEst.
Dec 16, 2024
CompletionEst.
Dec 16, 2024
Last update
Mar 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05243277
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Mar 16, 2023
Primary completion
Dec 16, 2024 (estimated)
Completion
Dec 16, 2024 (estimated)
Last update
Mar 28, 2023

Study contacts

Pascaline NEVEU, PhD
Contact
pascaline.neveu@intradef.gouv.fr
178651212 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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