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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02842151
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
* Willing and able to attend all scheduled study visits as required per protocol;
* Diagnosed with cataract in one or both eyes;
* Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
* Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Women of childbearing potential, pregnant, or breast-feeding;
* History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
* Previous intraocular or corneal surgery;
* Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
* Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02842151
Study Brief:
Protocol Section:
NCT02842151