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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT07051720
Eligibility Criteria:
Inclusion Criteria:
* Bilateral implantation of the same intraocular lens (IOL) model
* Expected postoperative best-corrected distance visual acuity (BCDVA) of 0.8 (decimal) or better
* Regular corneal astigmatism less than 1 diopter
Exclusion Criteria:
* Endothelial cell density \< 2,000 cells/mm²
* Required IOL power for emmetropia falls outside the available range of +10.0 D to +30.0 D
* Pupillary abnormalities
* Intraocular inflammation
* Recent ocular trauma or ocular surgery that is unresolved/unstable, or which may impair visual outcomes or increase patient risk
* History of corneal refractive surgery (e.g., LASIK, LASEK, PRK)
* Irregular astigmatism, as well as corneal abnormalities or opacities
* Conditions associated with an increased risk of zonular rupture, including capsular or zonular anomalies that may lead to IOL decentration or tilt, such as pseudoexfoliation syndrome, trauma, Marfan syndrome, among others
* Systemic or ocular diseases, or medications, that may impair vision, increase surgical risk, or confound study outcomes
* Clinically significant dry eye disease affecting visual function
* Anticipated need for retinal laser treatment or any other ocular surgical intervention during the study period
* Pregnancy, planned pregnancy, breastfeeding, or any condition associated with hormonal fluctuations that may induce refractive changes
* Continuous contact lens wear within the past 4 weeks
* Inability to understand and/or complete study questionnaires
* Advanced glaucoma with visual field defects
* Age-related macular degeneration (exudative or geographic form)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT07051720
Study Brief:
Protocol Section:
NCT07051720