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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06978556
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects age 45 years of age and older
2. Able to provide written informed consent and follow study instructions in English or German.
3. Desire for spectacle independence
4. Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))
5. Willing and able to return for scheduled follow-up examinations;
Exclusion Criteria:
1. Prior ophthalmic surgery or trauma
2. Zonular-defects, unstable bag
3. Macular pathologies
4. Excessive irregular astigmatism
6\. Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT06978556
Study Brief:
Protocol Section:
NCT06978556