Refractive Status and Accommodation Response Under Different Experimental Conditions.

Summary

Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected.

Conditions

• Accommodation Disorder
• Accommodative Fatigue
• Accommodative Inertia

Interventions

DEVICE

Visual acuity

VA will be measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

DEVICE

Objective refraction

Objective refraction will be measured using an auto-kerato-refractometer/aberrometer

DEVICE

Objective monocular accommodation amplitude measurement

Objective monocular accommodation amplitude measurements are obtained dynamically by measuring the subject's dioptric change while the participant focuses on a virtual object that moves from distance

DEVICE

Subjective monocular accommodation amplitude measurement with the "Push-Up" method

The subjective monocular accommodation amplitude measurements are carried out by the "push-up" method and proceeds as follows: * The ECP presents a near vision test card corresponding to a 0.8 (8/10) acuity line, or the smallest readable line if acuity is poor, or the smallest readable text. * Instructions to the subject: "Look at the smallest line of letters and try to see them clearly for as long as possible when I bring them closer; tell me when they start to blur and stay blurred. * The ECP slowly brings the test card closer * The ECP note the distance of the test card from the glasses as soon as the vision is blurred. Continue to move the test closer to check that vision remains blurred. The amount of accommodation in this eye is equal to the proximity (= 1/distance) of the test when the blur is just perceived.

DEVICE

Subjective monocular accommodation facility measurement with the "Rock" method:

The subjective monocular accommodation facility measurements are carried out by the "Rock" method and proceeds as follows: * The ECP presents at 40cm a near vision test card corresponding to 80% of the VA. * The ECP gives to the participant a flipper +/- 2 Dioptre * Instructions to the subject: "Look at the test" and add the -2.00 D (Sphere) flipper, as soon as it's clear, return the flipper to present a +2.00 D (Sphere), as soon as it's clear, return the flipper etc… You have to do the maximum number of rotations in one minute.

OTHER

CISS Questionnaire

This questionnaire relating to the use of the near vision will be submitted

OTHER

Difficulty assessment questionnaire

After each near vision measurement, the participant should rate, on a Visual Analogic Score (0-10), the difficulty encountered, from 0: extremely easy to 10: extremely difficult. The participant may also specify the reasons for the difficulty(ies) encountered during the measurement.

OTHER

Subjective evaluation questionnaire

A subjective evaluation questionnaire will be submitted to the participants at the end of the visit.

Sponsors & Collaborators

• Essilor International

  lead INDUSTRY

Principal Investigators

• Jérôme Gillet · ESSILOR INTERNATIONAL - Division Instruments

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-22

Primary Completion

2024-07-31

Completion

2024-12-31

Countries

• France

Study Locations