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:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT05954403
Eligibility Criteria:
Inclusion Criteria:
* Newborns and/or children from birth to 7 years old, Children from 8 years old affected with the following ocular defects: anophthalmia, microphthalmia, aniridia or anterior segment dysgnesis.whose parents will have properly evaluated risks and benefits of the study and will be given an informed consent to participate the protocol.
* Patients affiliated to the "Régime National d'Assurance Maladie". Inclusion of foreign patients will be possible through the French inclusion centers when they agreed to be charged for all medical fees.
* Adults affected with the following ocular defects: anophthalmia, microphthalmia, aniridia or anterior segment dysgenesis
* Adult patients under guardianship whose guardians will have properly evaluated risks and benefits of the study and will be given an informed consent to participate the protocol. Indeed, intellectual disability may be associated with the ocular defects and we will need to include these patients in order to evaluate incidence of this event.
* Adult patients able to properly evaluate risks and benefits of the study and to give their informed consent to participate to the protocol.
* Adult parents of an affected child participating to the study and willing to participate to the inheritance study (results of DNA analysis).
* Inclusion of foreign patients will be possible through the French inclusion centres when they agreed to be charged for all medical fees.
Pregnant women can be included in the study
Exclusion Criteria:
* No exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05954403
Study Brief:
Protocol Section:
NCT05954403