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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT04171518
Eligibility Criteria:
Inclusion Criteria
All criteria apply to each study eye:
Note: Study inclusion and exclusion criteria will be per the Catalys system instructions for use. A few key criteria are listed below:
* Patients scheduled for cataract surgery, including treatment with the Catalys Precision Laser System for anterior capsulotomy, phacofragmentation and the creation of single plane and multi-plane arc cuts/incisions in the cornea.
* Signed informed consent and privacy protection authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment and/or medical record in the governing countries
* At least 22 years of age at the time of consent.ion Criteria
Exclusion Criteria:
All criteria apply to each study eye:
* Presence of corneal ring and/or inlay implant(s), Descemetocele with impending corneal rupture)
* Severe corneal opacities, corneal abnormalities, significant corneal edema, or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule.
* Any contraindications to cataract surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04171518
Study Brief:
Protocol Section:
NCT04171518