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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT07112560
Eligibility Criteria:
Inclusion criteria:
* Patients aged 3 to 7 years at the time of consent signing.
* Patients followed in the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg).
* Holders of parental authority must be affiliated with or beneficiaries of the health insurance system.
* Holders of parental authority must be capable of understanding the objectives and risks related to the research, and able to provide dated and signed informed consent.
* Amblyopic patients must have amblyopia diagnosed by the reference screening method.
* Non-amblyopic patients must have undergone routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia.
* Screening must be performed in the Ophthalmology Department of CHU Strasbourg, unless a prior screening has been performed according to established guidelines and fully documented in a report by the patient's ophthalmologist (detailed results of the three standard screening tests).
* The screening examination must have been performed within the three months prior to the signing of the informed consent form.
Exclusion criteria:
* Amblyopic children currently undergoing treatment or having previously received treatment for amblyopia (optical correction, strabismus surgery, occlusion therapy, orthoptic rehabilitation).
* Children presenting conditions or states that may cause side effects related to the use of the virtual reality headset (epilepsy, neurological or developmental disorders, autism spectrum disorders, dizziness, nausea, claustrophobia, etc.).
* Inability to provide informed information to the patient or holders of parental authority (emergency situations, difficulties in patient comprehension, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT07112560
Study Brief:
Protocol Section:
NCT07112560