ClinicalTrials.gg
CompletedNCT04434521REFRACTUpdated Sep 13, 2022

Comparison of Different Refraction Measurements in Adults

An observational study in Vision Loss Night, sponsored by Direction Centrale du Service de Santé des Armées. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vision Loss Night

Browse trials for

03

In context

Vitamin A Deficiency

67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.

This study's enrollment of 17 is below the median of 258 across 17 observational studies indexed under Vitamin A Deficiency.

Browse Vitamin A Deficiency studies →

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
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults

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 subject;
  • Stereoscopic acuity ≤ 60 arc seconds.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Interventions

  • BehavioralQuestionnaire

    Questionnaire about habits in terms of near vision activities

  • OtherEye examination

    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

06

What researchers measure

Primary outcomes

  1. Maximum convex equivalent sphere values

    Maximum convex equivalent sphere values obtained by the different refraction procedures under study.

    Time frame: At visit 1 (day 1)

Secondary outcomes

  1. High contrast monocular acuity values

    High contrast monocular acuity values obtained by the different refraction procedures.

    Time frame: At visit 1 (day 1)

  2. Low contrast monocular acuity values

    Low contrast monocular acuity values obtained by the different refraction procedures.

    Time frame: At visit 1 (day 1)

  3. High contrast binocular acuity values

    High contrast binocular acuity values obtained by the different refraction procedures.

    Time frame: At visit 1 (day 1)

  4. Low contrast binocular acuity values

    Low contrast binocular acuity values obtained by the different refraction procedures.

    Time frame: At visit 1 (day 1)

  5. 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".

    Time frame: Difference between visit 1 (day 1) and visit 2

07

Study locations

1 site
  • Institut de Recherche Biomédicale des Armées
    Brétigny-sur-Orge, 91223, France
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

Ran from Mar 2021 to primary completion in May 2021, 1 month.

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

Registered
Jun 12, 2020
First posted
Jun 17, 2020
StartActual
Mar 5, 2021
Primary completionActual
May 3, 2021
CompletionActual
May 3, 2021
Last update
Sep 13, 2022
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 Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04434521
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Jun 17, 2020
Start date
Mar 5, 2021
Primary completion
May 3, 2021
Completion
May 3, 2021
Last update
Sep 13, 2022

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 completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion