REFRACT: Comparison of Different Refraction Measurements in Adults

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Recruiting
CT.gov ID
NCT04434521
Collaborator
(none)
65
1
13
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaire
  • Other: Eye examination

Study Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Different Refraction Measurements in Adults
Actual Study Start Date :
Mar 5, 2021
Anticipated Primary Completion Date :
Apr 5, 2022
Anticipated Study Completion Date :
Apr 5, 2022

Outcome Measures

Primary Outcome Measures

  1. Maximum convex equivalent sphere values [At visit 1 (day 1)]

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

Secondary Outcome Measures

  1. High contrast monocular acuity values [At visit 1 (day 1)]

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

  2. Low contrast monocular acuity values [At visit 1 (day 1)]

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

  3. High contrast binocular acuity values [At visit 1 (day 1)]

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

  4. Low contrast binocular acuity values [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 [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge France 91223

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT04434521
Other Study ID Numbers:
  • 2019PBMD04
  • 2020-A00259-30
First Posted:
Jun 17, 2020
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2021