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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT04523558
Eligibility Criteria:
Inclusion Criteria:
* Cataractous eyes with no comorbidity;
* Calculated IOL power is within the range of the study IOLs;
* Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
* Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
* Clear intraocular media other than cataract;
* Dilated pupil size large enough to visualize IOL axis markings postoperatively
* Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
* Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.
Exclusion Criteria:
* Age of patient \<50 years;
* Regular corneal astigmatism \>1.5D (measured by an automatic keratometry) in both eyes;
* Irregular astigmatism;
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements;
* Advanced or decompensated glaucoma;
* Significant dry eye;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04523558
Study Brief:
Protocol Section:
NCT04523558