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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT05462067
Eligibility Criteria:
Inclusion Criteria:
* Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions
* Age 18 and older
* Uncomplicated implantation of study IOLs
* No visual acuity limiting pathologies
* Clear intraocular media
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Written informed consent for participation in the study and data protection
Exclusion Criteria:
* Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders
* Postoperative CDVA \>0.2 log MAR
* Visual field loss which has impact on visual acuity
* Use of systemic or ocular medication that might affect vision
* Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus
* Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
* Patient participates in other clinical trial (former participation is no exclusion criterion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05462067
Study Brief:
Protocol Section:
NCT05462067