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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04967612
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between and including 18 and 50 years of age;
* Healthy eyes;
* Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
* Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Negative COVID19 screening test prior to every trial visit.
Exclusion Criteria:
* Subjects of less than 18 or more than 50 years of age;
* Monocular CDVA of dominant eye \< 1.0 decimal (\> 0.0 logMAR) without cycloplegia;
* Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
* Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
* Pseudophakic subjects;
* Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;
* Pathologic miosis;
* Intake of drugs affecting vision;
* Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
* Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;
* Hyperopes with more than +6 D refraction.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04967612
Study Brief:
Protocol Section:
NCT04967612