CompletedNot Applicable

Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)

Spain211 participantsStarted 2024-04-27

Plain-language summary

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

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: * Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. * Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a toric lens in one eye and a non-toric in the fellow eye. * Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection. Exclusion Criteria: * Subject currently participating in another investigational drug or device study. * Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation. * Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment. * Subject is pregnant or nursing at the time of enrollment.

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

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

Timeframe: Year 3-5 postoperative (Visit 1, Day 1)

Number of Eyes Experiencing an Ocular Adverse Event by Toricity

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Subjects Experiencing a Non-Ocular Adverse Event

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Device Deficiencies by Toricity

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Trial details

NCT IDNCT06166901

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-05

Results submitted2026-02-03

View on ClinicalTrials.gov More Aphakia trials

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.

What they're measuring

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

Timeframe: Year 3-5 postoperative (Visit 1, Day 1)

Number of Eyes Experiencing an Ocular Adverse Event by Toricity

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Subjects Experiencing a Non-Ocular Adverse Event

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Device Deficiencies by Toricity

Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)