Actively Recruiting
Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Led by Essilor International · Updated on 2024-08-21
378
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a multifunctional ophthalmic measuring device designed for eye examinations. This clinical investigation aims to refine the device's design by adjusting light source intensity, camera settings, and acquisition time to cover a wide range of patients. The study will also assess the safety and clinical performance of the device for measuring parameters related to conditions such as accommodation disorder, keratoconus, dry eye, and refractive errors. The investigation involves a single visit for each of the 378 participants, who will undergo measurements using the investigational device. The device will capture images and parameters of the anterior and posterior chambers of the eye, including axial biometry and physiological features of the anterior chamber. These measurements are collected during the visit to evaluate the device's ability to successfully acquire the intended data. Participants will be assessed during one visit at the study center, where various eye measurements will be taken using the device. Researchers will monitor the frequency of successful measurements to determine the device's clinical performance. Participants must be able to sit upright in front of the device for the evaluation. Safety and effectiveness will be recorded, and the study is expected to end in August 2025.
CONDITIONS
Brief Title
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Healthy children aged 4 to under 18 years with parental consent
- Participants attending the center for a routine consultation
- Participants affiliated with or beneficiaries of a social security scheme
- Participants able to sit upright in front of the investigational device
You will not qualify if you...
- Participants with implanted electronic medical devices (e.g., pacemaker, insulin pump, cochlear implant)
- Participants unable to sit upright or with injuries preventing head support on the device
- Participants deprived of liberty or under legal protection measures
- Participants not affiliated with a social security scheme
- Participants currently excluded from other investigations
- Pregnant or breastfeeding women
- Participants with neurological disorders, recent ocular surgeries (less than 2 weeks), or specific eye conditions (e.g., monophthalmia, strabismus, nystagmus)
- Participants with pupil size under 2 mm
- Participants with spherical equivalent refraction outside -20.00 to +20.00 diopters
- Participants with astigmatism greater than 8.00 diopters
- Participants with corneal power outside 35-55 diopters
- Participants with axial length outside 18-34 mm
- Participants with intraocular pressure outside 7-50 mm Hg
- Essilor International/Luxottica employees
- Children with the above exclusion criteria specific to their age group (neurological disorders, recent ocular surgery, monophthalmia, fixation disorders, pupil size under 2 mm, refraction and astigmatism limits, axial length range)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo measurements of physiological parameters and axial biometry of the eye using the investigational device during a routine consultation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
West Ophta
Rennes, France, 35000
Actively Recruiting
Research Team
P
Paul-Henri Prevot
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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