Refractive Status and Accommodation Response Under Different Experimental Conditions.

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.

Study Overview

• Status: Recruiting
• Conditions: Accommodation Disorder; Accommodative Fatigue; Accommodative Inertia
• Intervention / Treatment: 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

Detailed Description

Clinical Development stage and rationale

The clinical development stage is pilot stage as defined in ISO 14155:2020 (Annex I section 1.3.2).This clinical investigation is an exploratory clinical investigation as mentioned in the Medical Device Regulation EU 745/2017, also named early feasibility clinical investigation in the ISO 14155:2020. The necessity of such clinical investigations is more precisely described by the Food and Drug Administration (FDA) (Attachment E CDRH Final Guidance Cover Sheet) and Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), where they detail the importance of exploratory studies in pivotal investigation design.

Medical devices often undergo design improvement during development, with refinement during lifecycles beginning with early research, extending through investigational use and initial marketing of the approved or cleared product, and continuing to subsequently approved or cleared commercial device versions.

Objectives and hypotheses of the clinical investigation

This clinical investigation explores new ways of measuring accommodative response, particularly regarding the dynamics and amplitude of response: we chose to vary several parameters.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thierry Laloux; Phone Number: +33 (1) 55 96 54 05; Email: lalouxt@essilor.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Essilor International - Ci&T 2
    • Contact: Jérôme Gillet; Phone Number: +33 (0)1 49 80 63 40; Email: gilletj@essilor.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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),
• Subjects under exclusion period from another investigation,
• 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 ...).
• Pupil abnormality (unusual shape, size <3mm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Closed-field Aberrometer; Objective refraction at different distances with Shack-Hartmann Aberrometer

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Essilor International
• Investigators: Principal Investigator: Jérôme Gillet, ESSILOR INTERNATIONAL - Division Instruments

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: WS10370; 2023-A02153-42 (Other Identifier: ANSM (France))

Drug and device information, study documents

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