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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT05799950
Eligibility Criteria:
Key Inclusion Criteria:
* Subject is implanted with one of the study IOL models between 3 and 5 years previously.
* Subject follow-up is expected to be possible during the duration of the study.
* Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
* Documented medical history and required pre-operative baseline information is available for retrospective data collection.
Key Exclusion Criteria:
* Subject is participating in a separate investigational drug or device study.
* Pregnancy at the time of enrollment.
Sex:
ALL
Study:
NCT05799950
Study Brief:
Protocol Section:
NCT05799950