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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT05488769
Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
* Visually significant age-related cataracts bilaterally.
* Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
* Gender: Males and Females.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Clear intraocular media other than cataract.
* Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
* IOL powers between 6D and 30D, T2-T6.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
* Previous ocular or refractive surgery
* Ocular surface disease/Dry Eye Disease
* Intraoperative complications during procedure
* Glaucoma, including well-controlled
* Any disorders that reduce binocular vision (ie Strabismus)
* Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Sex:
ALL
Study:
NCT05488769
Study Brief:
Protocol Section:
NCT05488769