Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331780
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-12
Brief Title:
Refractive Status and Accommodation Response Under Different Experimental Conditions
Sponsor:
Essilor International
Organization:
Essilor International
Study Overview
Official Title:
Refractive Status and Accommodation Response Under Different Experimental Conditions
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Clinical Development stage and rationale
The clinical development stage is pilot stage as defined in ISO 141552020 Annex I section 132This clinical investigation is an exploratory clinical investigation as mentioned in the Medical Device Regulation EU 7452017 also named early feasibility clinical investigation in the ISO 141552020 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
The clinical development stage is pilot stage as defined in ISO 141552020 Annex I section 132This clinical investigation is an exploratory clinical investigation as mentioned in the Medical Device Regulation EU 7452017 also named early feasibility clinical investigation in the ISO 141552020 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02153-42 | OTHER | ANSM France | None |