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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT04866706
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 years and older;
* Candidate for cataract surgery via phacoemulsification;
* Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment;
* Eligible for the use of VISIOL as indicated in the instructions for use;
* Written informed consent.
Exclusion Criteria:
* Known allergy or hypersensitivity to any of VISIOL components;
* Known pregnancy or breast feeding;
* Participation in any other clinical research study within the last 90 days;
* Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection);
* Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04866706
Study Brief:
Protocol Section:
NCT04866706