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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT06345820
Eligibility Criteria:
Inclusion Criteria:
* Bilateral cataract
* Age 21 or older
* Visual acuity \> 0.05
* Axial length: 22.00-26.00mm
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Written informed consent prior to surgery
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
* Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)
* Corneal decompensation or corneal endothelial cell insufficiency
* Amblyopia
* Previous ocular surgery or trauma
* Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
* Astigmatism with the need for a toric IOL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
105 Years
Study:
NCT06345820
Study Brief:
Protocol Section:
NCT06345820