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OpenTrials
Completed

NCT Number: NCT04434521

Comparison of Different Refraction Measurements in Adults

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 ;
  • Non-presbyopic subject;
  • Stereoscopic acuity ≤ 60 arc seconds.

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).

Treatment and study plan

Questionnaire

Behavioral

Questionnaire about habits in terms of near vision activities

Eye examination

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. High contrast monocular acuity values

    Time frame: At visit 1 (day 1)

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

  2. Low contrast monocular acuity values

    Time frame: At visit 1 (day 1)

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

  3. High contrast binocular acuity values

    Time frame: At visit 1 (day 1)

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

  4. Low contrast binocular acuity values

    Time frame: At visit 1 (day 1)

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

  5. Difference between binocular perceptual assessment scores before and after subjective adjustment

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

    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".

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: REFRACT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2020
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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