Accommodation Disorder Clinical Trial
Official title:
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.
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. ;
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