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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT04005651
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults ages 45 or older on the day of screening who have cataract(s) in one or both eyes
* Capability to understand and sign an Ethics Committee (EC) approved informed consent form and privacy authorization
* Corrected visual acuity projected by potential acuity meter (PAM) testing or other potential visual acuity test procedure to be better than 20/32 after intraocular lens implantation
* Clear intraocular media other than cataract
* Calculated IOL power is within the range of the study IOLs
* Dilated pupil size large enough to visualize IOL axis markings postoperatively
* Willing and able to conform to the study requirements
Exclusion Criteria:
* Subjects with diagnosed degenerative visual disoerders (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 age-related macular degeneration (AMD) suspicious eyes as determined by optical coherence tomography (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
* Greater than 1 diopter of pre-operative corneal astigmatism or any irregular astigmatism
* Previous intraocular or corneal surgery
* Traumatic cataract
* History or presence of macular edema
* Pregnant,lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study
* Concurrent or previous (within 30 days) participation in another drug or device investigation
* Instability of keratometry or biometry measurements
* Ocular hypertension or glaucoma
* Significant dry eye
* Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on eCRF)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04005651
Study Brief:
Protocol Section:
NCT04005651