CompletedNot Applicable

Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

United States101 participantsStarted 2023-07-10

Plain-language summary

The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation. The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision? Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following: * consent to participate in the study * allow researchers to access their personal medical records * undergo a series of tests to assess the position of their IOLs and quality of vision Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)

Timeframe: Visit 1

Trial details

NCT IDNCT05827133

SponsorEast Coast Institute for Research

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2024-07-23

View on ClinicalTrials.gov More Cataract trials