Vision Loss NightREFRACTNCT04434521
Comparison of Different Refraction Measurements in Adults
An observational study of Vision Loss Night, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Loss Night
- What is being tested?
- Questionnaire and Eye examination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2021to 3 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Age over 18 ;
- Non-presbyopic subject;
- Stereoscopic acuity ≤ 60 arc seconds.
Who cannot join
- Accommodative insufficiency;
- Accommodative inertia;
- Compensation by orthokeratology (i.e. night lenses);
- Present or past binocular pathology (strabismus or amblyopia);
- Pregnant or nursing woman;
- Incomprehension of French (written and spoken).
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
About this study
The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.
The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.
Read more
The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.
The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.
- Conditions
- Vision Loss Night
- Being tested
- Questionnaire, Eye examination
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire about habits in terms of near vision activities
Eye examinationOther
The eye examination involves the following measurements:
- Distant vision phoria with Thorington method
- Close vision with Thorington method
- Objective eye-to-eye refraction with self-refractometer
- Binocular objective refraction with autorefractometer
- Monocular/biocular/binocular refraction with Nidek TS610
- SiView automatic refraction
- Humphriss binocular refraction
- MOU Binocular refraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum convex equivalent sphere values
Maximum convex equivalent sphere values obtained by the different refraction procedures under study.
Measured: At visit 1 (day 1)
Secondary outcomes (5)
High contrast monocular acuity values
High contrast monocular acuity values obtained by the different refraction procedures.
Measured: At visit 1 (day 1)
Low contrast monocular acuity values
Low contrast monocular acuity values obtained by the different refraction procedures.
Measured: At visit 1 (day 1)
High contrast binocular acuity values
High contrast binocular acuity values obtained by the different refraction procedures.
Measured: At visit 1 (day 1)
Low contrast binocular acuity values
Low contrast binocular acuity values obtained by the different refraction procedures.
Measured: At visit 1 (day 1)
Difference between binocular perceptual assessment scores before and after subjective adjustment
Difference between binocular perceptual assessment scores obtained by the different refractive procedures before and after subjective adjustment.
Binocular perceptual assessment score will be obtained using visual analogue faces. The score will range from "excellent comfort" to "unbearable".
Measured: Difference between visit 1 (day 1) and visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start5 Mar 2021
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision Loss NightStudies 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
- 17 participants (actual)
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
- NCT04434521
- Sponsor's protocol ID
- 2019PBMD04
- Other IDs
- 2020-A00259-30
- Acronym
- REFRACT
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2020
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Refraction Measurements in Adults
- ClinicalTrials.gov ID
- NCT04434521
- Acronym / sponsor ID
- REFRACT / 2019PBMD04
- Conditions
- Vision Loss Night
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 17 Jun 2020 (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.
The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.
The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.
The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.
The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (3 listed)
- Age over 18 ;
- Non-presbyopic subject;
- Stereoscopic acuity ≤ 60 arc seconds.
Key exclusion criteria (6 listed)
- Accommodative insufficiency;
- Accommodative inertia;
- Compensation by orthokeratology (i.e. night lenses);
- Present or past binocular pathology (strabismus or amblyopia);
- Pregnant or nursing woman;
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 |
|---|---|---|
| QuestionnaireQuestionnaire about habits in terms of near vision activities | Behavioural | – |
| Eye examinationThe eye examination involves the following measurements: * Distant vision phoria with Thorington method * Close vision with Thorington method * Objective eye-to-eye refraction with self-refractometer * Binocular objective refraction with autorefractometer * Monocular/biocular/binocular refraction with Nidek TS610 * SiView automatic refraction * Humphriss binocular refraction * MOU Binocular refraction | Other | – |
Primary outcome
Maximum convex equivalent sphere values
Time frame: At visit 1 (day 1)
Maximum convex equivalent sphere values obtained by the different refraction procedures under study.
5 secondary outcomes
High contrast monocular acuity values
Time frame: At visit 1 (day 1)
Low contrast monocular acuity values
Time frame: At visit 1 (day 1)
High contrast binocular acuity values
Time frame: At visit 1 (day 1)
Low contrast binocular acuity values
Time frame: At visit 1 (day 1)
Difference between binocular perceptual assessment scores before and after subjective adjustment
Time frame: Difference between visit 1 (day 1) and visit 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vision Loss Night, 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 6 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: finished, as of the sponsor's last update on 13 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum convex equivalent sphere values (time frame: At visit 1 (day 1)). 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 13 Sep 2022.