NCT06331780

Refractive Status and Accommodation Response Under Different Experimental Conditions.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Accommodation Disorder
• Accommodative Fatigue
• Accommodative Inertia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-22
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2024-03-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: France