Comparison of Different Refraction Measurements in Adults

Vision Loss Night Clinical Trial

— REFRACT  

Official title:

Comparison of Different Refraction Measurements in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434521
• Other study ID #: 2019PBMD04
• Secondary ID: 2020-A00259-30
• Status: Completed
• Start date: March 5, 2021
• Est. completion date: May 3, 2021

Study information

• Verified date: September 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Night Blindness
• Vision Loss Night

Intervention

Behavioral:
• Questionnaire
Questionnaire about habits in terms of near vision activities

Other:
• Eye 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

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum convex equivalent sphere values	Maximum convex equivalent sphere values obtained by the different refraction procedures under study.	At visit 1 (day 1)
Secondary	High contrast monocular acuity values	High contrast monocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Secondary	Low contrast monocular acuity values	Low contrast monocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Secondary	High contrast binocular acuity values	High contrast binocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Secondary	Low contrast binocular acuity values	Low contrast binocular acuity values obtained by the different refraction procedures.	At visit 1 (day 1)
Secondary	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