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PanOptix lens safety confirmed years after surgery

NCT ID NCT06166901

Disease control Sponsor: Alcon Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety and performance of AcrySof PanOptix trifocal lenses in 211 people who had them implanted in both eyes 3 to 5 years earlier. Researchers checked vision and recorded any eye problems or device issues. The goal was to make sure these lenses remain safe and effective over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

211 people

The number who actually took part.

Started

Apr 2024

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Aphakia astigmatism cataract congenital primary aphakia presbyopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aphakia Astigmatism Presbyopia

Contacts and locations

Locations

  • Barraquer Ophthalmology Center

    Barcelona, 08021, Spain

  • Clinicas Novovision - Clinica Madrid

    Madrid, 28046, Spain

  • Hospital Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitari General de Catalunya

    Sabadell, Barcelona, 8205, Spain

  • Institut Catala de la Retina - Sarria

    Barcelona, 8022, Spain

  • Miranza IOA

    Madrid, 28033, Spain

  • Oftalvist Jerez - HLA Puerta del Sur

    Jerez de la Frontera, Cadiz, 11408, Spain

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