ClinicalTrials.gg
CompletedNCT07161635Updated Oct 19, 2026

Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs

An interventional study of Clareon PanOptix Pro/Pro Toric Trifocal IOL and Phacoemulsification in Aphakia and Presbyopia, sponsored by Alcon Research. Completed at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.

Read the detailed description

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.

02

Conditions studied

  • Aphakia
  • Presbyopia

Keywords

  • Cataract
  • Eye Surgery
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 110 is close to the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);
  • Subject must be able to understand and sign an approved form;
  • Subject is willing to complete all the required study visits for the duration of the study;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Ocular conditions as specified in the protocol;
  • Subjects who desire monovision correction;
  • Previous intraocular or corneal surgery;
  • Other protocol-defined exclusion criteria may apply.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Clareon PanOptix Pro/Pro Toric Trifocal IOL

    The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

    Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL · Procedure: Phacoemulsification

Interventions

  • DeviceClareon PanOptix Pro/Pro Toric Trifocal IOL

    Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

    Also known as: Clareon PanOptix Pro Trifocal IOL Models PXYWT0, PXCWT0, PXYAT0, PXCAT0, Clareon PanOptix Pro Trifocal Toric IOL Models PXYWT3- PXYWT6, PXCWT3-T6, PXYAT3-PXYAT6, PXCAT3-PXCAT6

  • ProcedurePhacoemulsification

    Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.

06

What researchers measure

Primary outcomes

  1. Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)

    Visual Acuity (VA) will be assessed for both eyes together (binocular) using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.

    Time frame: Month 1 and Month 6 postoperative

07

Study locations

5 sites
  • Wolstan & Goldberg Eye Associates
    Torrance, California 90505, United States
  • Moyes Eye Center
    Kansas City, Missouri 64154, United States
  • Carolina Eyecare Physicians LLC
    Mt. Pleasant, South Carolina 29464, United States
  • Houston Eye Associates
    Houston, Texas 77008, United States
  • The Eye Institute of Utah
    Salt Lake City, Utah 84107, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 13, 2026
Primary completion
Oct 8, 2026→Oct 7, 2026
Oct 19, 2026
Study completion
Oct 8, 2026→Oct 7, 2026
Oct 19, 2026
Show all 2 updates
  1. Oct 19, 2026
    Primary completion Oct 8, 2026→Oct 7, 2026
    Study completion Oct 8, 2026→Oct 7, 2026
  2. Oct 13, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07161635
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Oct 14, 2025
Primary completion
Oct 7, 2026
Completion
Oct 7, 2026
Last update
Oct 19, 2026

Study contacts

Sr. Principal Clinical Trial Operations, Surgical
study director · Alcon Research LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion