Comportement Visuo-postural Des Adolescents Myopes et Non Myopes (CALYPSO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Essilor International
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Working distance using motion capture system
Study Overview
Brief Summary
The goal of this observational study is to learn whether different types of eyeglasses prescription and different types of lenses change how close teenagers hold objects when looking at them up close. The study includes adolescents who are non-myopic and adolescents who are myopic and wear either single-vision lenses or lenses slowing down myopia progression.
The main questions it aims to answer are:
Do teenagers in these three groups use different average working distances (eye-to-object distance) during everyday tasks?
Does wearing Essilor® Stellest® lenses change working distance compared with wearing single-vision lenses?
Researchers will compare the three groups to see if their working distances differ.
Participants will:
Complete an initial optometric eye examination.
Come for a second visit where they perform everyday activities while wearing a motion-capture system that measures how they move and how far they hold objects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteer adolescent, fluent in French, able to follow protocol and read and write
- •Aged between 12 and 17 years and 6 months
- •Adolescent with no history, according to the participant and/or their legal representatives, of any pathology, deficit, or disorder that could interfere with visual or cognitive functions.
- •If the subject wears glasses, they must have an ophthalmic prescription dated within the last year, certifying that a consultation was carried out during the previous year
- •If the subject wears Essilor® Stellest® 1.0 lenses, they must have worn them for at least two (2) consecutive months prior to inclusion in the study.
- •If the subject is nearsighted: -6.5D ≤ equivalent sphere ≤ -0.5D with usual correction
- •If the subject is not nearsighted: -0.5 < equivalent sphere ≤ +2.5
Exclusion Criteria
- •Age < 12 years
- •Age > 17 years and 6 months
- •Pregnant or breastfeeding women (Article L1121-5)
- •Persons (legal representatives or subjects) deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
- •Participants who are currently excluded from another study
- •All categories of persons who are particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)
- •Declared neurological deficit, in particular a history of epileptic pathology or sensorimotor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
- •Severe declared eye disease involving loss of visual field, such as glaucoma, involving loss of acuity and severe discomfort in low-light or overly bright environments, such as retinitis pigmentosa, or declared and treated dry eye syndrome.
- •Gougerot-Sjögren syndrome or declared dry eye syndrome
- •Declared aphakia or pseudophakia (intraocular implant)
- •Declared systemic pathology, medical treatment, or medication with an effect on vision
- •People with declared muscle paralysis
- •Binocular vision problems such as amblyopia, strabismus, or nystagmus
- •Children of employees or employees of Essilor International, Luxottica, GrandVision, and their subsidiaries
- •Individuals who have undergone previous refractive surgery, have a history of strabismus surgery, or have a history of any type of eye surgery
Arms & Interventions
non-myopic teenagers
Intervention: Ophtalmic measurements (Device)
non-myopic teenagers
Intervention: Visuo-postual measurements (Behavioral)
myopic teenagers wearing Essilor® Stellest® lenses
Intervention: Ophtalmic measurements (Device)
myopic teenagers wearing Essilor® Stellest® lenses
Intervention: Visuo-postual measurements (Behavioral)
myopic teenagers wearing single vision lenses
Worn lenses do not have a myopia-control effect
Intervention: Ophtalmic measurements (Device)
myopic teenagers wearing single vision lenses
Worn lenses do not have a myopia-control effect
Intervention: Visuo-postual measurements (Behavioral)
Outcomes
Primary Outcomes
Working distance using motion capture system
Time Frame: From enrollment to 3 months after enrollment
Quantitative assessment of working distance in meters during near vision tasks using a motion capture system
Secondary Outcomes
- Gaze behavior during near vision tasks accessed with an eye-tracking system(From enrollment to 3 months after enrollment)
- Posture, eye-head coordination during near-vision tasks (with motion capture system)(From enrollment to 3 months after enrollment)
- Correlation coefficient (R2) between optometric profile and near-vision behavior(From enrollment to 3 months after enrollment)