Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix (NCT05796453) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
United States, Puerto Rico470 participantsStarted 2023-09-19
Plain-language summary
The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.
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.
Key Inclusion Criteria:
* Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
* Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
* Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
* Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
* Subject is currently participating in another investigational drug or device study.
* Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
* Subject is pregnant at the time of enrollment.
* Other protocol-defined exclusion criteria may apply.
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.
1Since this study is specifically following patients who already have the Clareon Vivity or Clareon PanOptix lenses implanted, does my situation — whether I have aphakia, astigmatism, or presbyopia — match the kind of patients being tracked, and does that affect whether their real-world safety data would be relevant to my own lens choice?
2The trial is actively collecting data on adverse events and device deficiencies with these two specific lenses — are there any safety signals or complications that have come up so far that I should weigh before deciding between the Vivity extended-depth-of-focus lens and the PanOptix trifocal lens?
3Since this is a post-market follow-up study rather than a traditional phase trial, how does that change what we already know about the safety and effectiveness of these lenses compared to the clinical trials that led to their approval?
4One of the key things being measured is binocular best corrected distance visual acuity over time — what does that mean for my realistic expectations about how well I'd be able to see at different distances, especially since I also have astigmatism or presbyopia?
5Given that this study is no longer recruiting, could my doctor still use the ongoing safety and outcomes data being collected here to inform the decision about which lens — or whether a standard monofocal lens — might be a better fit for my specific vision needs and lifestyle?
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
1
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit