Trials / Recruiting
RecruitingNCT06565091
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 378 (estimated)
- Sponsor
- Essilor International · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Accepted
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.
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 and/or effectiveness of the medical device and determine whether the system is suitable for the purposes and populations for which it is intended.
Conditions
- Accommodation Disorder
- Keratoconus
- Dry Eye
- Refractive Errors
- Accommodative Fatigue
- Accommodative Inertia
- Aberration, Corneal Wavefront
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Measurements of physiological parameters of the anterior chamber | Acquisition by the investigational device |
| DEVICE | Measurements of the Axial biometry | Acquisition by the investigational device |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2025-08-01
- Completion
- 2025-08-01
- First posted
- 2024-08-21
- Last updated
- 2024-08-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06565091. Inclusion in this directory is not an endorsement.