Actively Recruiting
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Led by Essilor International · Updated on 2024-08-21
378
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older and healthy children 4 years and older but under 18 years
- Participants coming to the center for a routine consultation
- Participants affiliated with a social security scheme or beneficiaries of such a scheme
- Participants able to sit upright in front of the investigational device
- For healthy children, parents must have consented to their child's participation
You will not qualify if you...
- Participants with implanted electronic medical devices such as pacemaker, insulin pump, cochlear implant, electrostimulator, or hearing aid
- Participants unable to sit upright or with injuries preventing head support on the device's rest
- Participants deprived of liberty by judicial or administrative decision or hospitalized without consent
- Participants under legal protection measures or unable to provide consent
- Participants not affiliated with a social security scheme or beneficiaries
- Participants currently excluded from other investigations
- Women who are pregnant or breastfeeding
- Participants with neurological disorders, especially epilepsy or sensory motor issues
- Participants with recent ocular surgeries including refractive surgery less than 2 weeks prior
- ESSILOR International/ESSILOR Luxottica employees
- Participants with monophthalmia
- Participants with obvious fixation disorders, strabismus, or nystagmus
- For tonometry measurements: participants with edematous or ulcerated cornea, post-keratoplasty or ocular surgery, severe keratoconus with hydrops risk, retinal detachment, anterior/posterior chamber sulcus IOL, intrastromal rings, or Kamra lens
- Participants with pupil size less than 2 mm
- Participants with spherical equivalent refraction outside -20.00 to +20.00 D
- Participants with astigmatism greater than 8.00 D
- Participants with corneal power outside 35-55 D
- Participants with axial length outside 18-34 mm
- Participants with intraocular pressure outside 7-50 mm Hg
- Participants previously enrolled in this clinical investigation
- Healthy children with neurological disorders, recent ocular surgeries, monophthalmia, fixation disorders, pupil less than 2 mm, spherical equivalent refraction outside -20.00 to +20.00 D, astigmatism greater than 8.00 D, or axial length outside 18-34 mm
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West Ophta
Rennes, France, 35000
Actively Recruiting
Research Team
P
Paul-Henri Prevot
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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