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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT05827133
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
* Willing to undergo an eye exam with pupil dilation
Exclusion Criteria:
* Moderate to severe posterior capsule opacification (2+ or more)
* Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
* Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
* Any previous ocular surgery (excluding YAG, LASIK, PRK)
* Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
* Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
* Women who are pregnant at the time of screening (based on self-reported history)
* Medical or other problems which in the opinion of the investigator will render study participation unsafe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05827133
Study Brief:
Protocol Section:
NCT05827133