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.
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
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
55
VA will be measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer
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
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.
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.
This questionnaire relating to the use of the near vision will be submitted
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.
A subjective evaluation questionnaire will be submitted to the participants at the end of the visit.
Essilor International - Ci&T 2
Créteil, France
RECRUITINGAccommodative response measured with closed-field aberrometer with different target displacement methods
Accommodative response (Dioptries)
Time frame: One day (measurements are taken during the single visit)
Accommodative response measured with closed-field aberrometer with different displayed targets
Accommodative response (Dioptries)
Time frame: 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)
Time frame: One day (measurements are taken during the single visit)
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