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Eye lens implant safety study pulled before starting

NCT ID NCT06541795

Knowledge-focused 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study was designed to check the long-term safety and performance of AcrySof IQ Vivity lens implants in people who had them in both eyes for 3 to 5 years. It was a real-world observation, not a treatment test. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AcrySof IQ Vivity Extended Vision intraocular lens (IOL) and AcrySof IQ Vivity Toric Extended Vision IOL

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.

Expected to start

Jun 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

22 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.

Key Inclusion Criteria: * 22 years old or older at Visit 1. * Able to understand and sign an approved informed consent form. * Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment. * Documented medical history and required pre-operative baseline information available for retrospective data collection. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation. * Pregnant or nursing at the time of enrollment. * Childbirth after IOL implantation. * Other protocol-specified exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Aphakia cataract congenital primary aphakia presbyopia

As listed by the trial registrant

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

Aphakia Presbyopia Residual refractive cylinder

Contacts and locations

Locations

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas, 76134, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.