Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565091
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical investigation is to evaluate the clinical utility of a multifunctional measuring device for Ophtalmology
The results of this clinical investigation will be used to refine and validate the device design
378 participants total will be included in the trial each having only one visit at the investigation center
The results of this clinical investigation will be used to refine and validate the device design
378 participants total will be included in the trial each having only one visit at the investigation center
Detailed Description:
The objectives of this clinical investigation are
Develop the device in clinical conditions refine the intensity and gain of the light sources and the acquisition time of the cameras and photodiodes in order to cover the targeted population
Evaluate the safety and clinical performance andor effectiveness of the medical device and determine whether the system is suitable for the purposes and populations for which it is intended
Develop the device in clinical conditions refine the intensity and gain of the light sources and the acquisition time of the cameras and photodiodes in order to cover the targeted population
Evaluate the safety and clinical performance andor effectiveness of the medical device and determine whether the system is suitable for the purposes and populations for which it is intended
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None