Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07440134
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT07440134
Study Brief:
Protocol Section:
NCT07440134