Refractive Status and Accommodation Response Under Different Experimental Conditions.

NCT06331780 | Recruiting

• 2 other identifiers: WS103702023-A02153-42
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Accommodative response measured with closed-field aberrometer with different target displacement methods

  Accommodative response (Dioptries)

  One day (measurements are taken during the single visit)

• Accommodative response measured with closed-field aberrometer with different displayed targets

  Accommodative response (Dioptries)

  One day (measurements are taken during the single visit)

• Objective refraction measured with closed-field aberrometer and two camera exposure times

  Sphere (Dioptries), Cylinder (Dioptries), Axis (°) and High Order Aberrations (Zernike polynomials)

  One day (measurements are taken during the single visit)

Study Arms (1)

Closed-field Aberrometer

EXPERIMENTAL

Objective refraction at different distances with Shack-Hartmann Aberrometer

Device: Visual acuity; Device: Objective refraction; Device: Objective monocular accommodation amplitude measurement; Device: Subjective monocular accommodation amplitude measurement with the "Push-Up" method; Device: Subjective monocular accommodation facility measurement with the "Rock" method:; Other: CISS Questionnaire; Other: Difficulty assessment questionnaire; Other: Subjective evaluation questionnaire

Interventions

Visual acuity DEVICE

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

Closed-field Aberrometer

Objective refraction DEVICE

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

Closed-field Aberrometer

Objective monocular accommodation amplitude measurement DEVICE

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

Closed-field Aberrometer

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

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.

Closed-field Aberrometer

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

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.

Closed-field Aberrometer

CISS Questionnaire OTHER

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

Closed-field Aberrometer

Difficulty assessment questionnaire OTHER

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.

Closed-field Aberrometer

Subjective evaluation questionnaire OTHER

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

Closed-field Aberrometer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer: man or woman from 18 to 40 years old,
• Subject declares that his last visit to an ophthalmologist was less than 12 months ago,
• Subjects without a reported pathology, deficit or disorder that can interfere with visual or cognitive functions,
• Subjects, healthy volunteers who have been fully informed of the investigation and signed the informed consent form of the investigation,
• Subjects available for the investigation visits (at least 2 hours),
• Subjects able to appoint a visit in the investigator's site,
• Subjects able to read and understand the protocol (in French), follow the instructions, and give their informed consent approval.

You may not qualify if:

• Subjects with spherical equivalent wearing compensation (or fully compensate by contact lenses) ranging out from -3.00 to + 3.00 Dioptres in both eyes,
• Subjects with an astigmatism wearing compensation (or fully compensate by contact lenses) more than 1.00 Dioptres (\>1,00DC) in both eyes,
• Subjects with a best compensated monocular VA \< 8/10 (\>0.1logMAR),
• Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice, etc.) or unable to express their consent (see Article L 1121-8 of the CSP)
• Persons deprived of their liberty by judicial or administrative decision and persons hospitalised without their consent (article L1121-6 of the CSP),
• Women pregnant or breastfeeding; (Article L1121-5),
• Subjects with a reported neurologic disorder, particularly epileptic or sensory motor troubles,
• Subjects with implanted electronic medical device such as (pacemaker or hearing aid),
• Subjects with a reported severe ocular disease leading to a visual field decrease, VA deficiency or glare sensitivity,
• Subjects with monophtalmia
• Subjects who had ocular surgeries (including aphakia or pseudophakia (intraocular lenses), refractive surgery or trauma),
• Subjects who are ESSILOR INTERNATIONAL employees
• Subjects who are not affiliated to a social security scheme or are beneficiaries of such a scheme (article L1121-8-1 of the CSP).
• Subject with fixation disorder: impossibility to maintain fixation on visual target.
• Subjects who cannot stay comfortable during the tests (e.g. with neck pain ...).

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor International - Ci&T 2

Créteil, 94000, France

RECRUITING

MeSH Terms

Interventions

Visual Acuity; Coping Inventory for Stressful Situations

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Jérôme Gillet

  ESSILOR INTERNATIONAL - Division Instruments

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Laloux

CONTACT

+33 (1) 55 96 54 05; lalouxt@essilor.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: February 22, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

FR (1)