Comparison of Different Refraction Measurements in Adults

NCT04434521 | Completed

• 2 other identifiers: 2019PBMD042020-A00259-30
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Vision Loss Night

Outcome Measures

Primary Outcomes (1)

• Maximum convex equivalent sphere values

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

  At visit 1 (day 1)

Secondary Outcomes (5)

• High contrast monocular acuity values

  At visit 1 (day 1)

• Low contrast monocular acuity values

  At visit 1 (day 1)

• High contrast binocular acuity values

  At visit 1 (day 1)

• Low contrast binocular acuity values

  At visit 1 (day 1)

• Difference between binocular perceptual assessment scores before and after subjective adjustment

  Difference between visit 1 (day 1) and visit 2

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: March 5, 2021
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

FR (1)