Visual FatigueALGO-HMDNCT05243277
Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm
An observational study of Visual Fatigue, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Fatigue
- What is being tested?
- Oculomotor tests
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2023to 16 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population is composed of healthy subjectfs with no history of visual disorders.
Who may be able to join
- Age over 18
- Non-presbyopic
- Stereoscopic acuity ≤ 60 min of arc
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Pascaline NEVEU, PhD, 178651212 ext. +33, pascaline.neveu@intradef.gouv.fr
About this study
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.
- Conditions
- Visual Fatigue
- Being tested
- Oculomotor tests
- Keywords
- virtual reality
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculomotor testsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the study (20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start16 Mar 2023
- Primary completion16 Dec 2024 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243277
- Sponsor's protocol ID
- 2021PBMD04
- Other IDs
- 2021-A02286-35
- Acronym
- ALGO-HMD
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm
- ClinicalTrials.gov ID
- NCT05243277
- Acronym / sponsor ID
- ALGO-HMD / 2021PBMD04
- Conditions
- Visual Fatigue
- Keywords
- virtual reality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of healthy subjectfs with no history of visual disorders.
Key inclusion criteria (3 listed)
- Age over 18
- Non-presbyopic
- Stereoscopic acuity ≤ 60 min of arc
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculomotor testsThere 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. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Fatigue, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascaline NEVEU, PhD (178651212 ext. +33, pascaline.neveu@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of oculomotor response to a stimulation generating jumps in vergence demand (time frame: Until the end of the study (20 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.