Comparison of Different Refraction Measurements in Adults (REFRACT)

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 Overview

• Status: Completed
• Conditions: Vision Loss Night
• Intervention / Treatment: Behavioral: Questionnaire; Other: Eye examination

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum convex equivalent sphere values	Maximum convex equivalent sphere values obtained by the different refraction procedures under study.	At visit 1 (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High contrast monocular acuity values	High contrast monocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Low contrast monocular acuity values	Low contrast monocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
High contrast binocular acuity values	High contrast binocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Low contrast binocular acuity values	Low contrast binocular acuity values obtained by the different refraction procedures.	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".	Difference between visit 1 (day 1) and visit 2

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Vision Disorders; Night Blindness
• Other Study ID Numbers: 2019PBMD04; 2020-A00259-30 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No