AphakiaNCT05796453

Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

A study testing Clareon Vivity IOL - Non Toric, Clareon Vivity IOL - Toric and Clareon PanOptix Trifocal IOL - Non Toric in people with Aphakia and Astigmatism, run by Alcon Research at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aphakia, Astigmatism, Presbyopia
What is being tested?: Clareon Vivity IOL - Non Toric, Clareon Vivity IOL - Toric and Clareon PanOptix Trifocal IOL - Non Toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 470 participants
Where: 7 sitesin 2 countries
Study dates: 19 Sep 2023to 21 Aug 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

Chu Eye Institute
Fort Worth, Texas, 76107
Levenson Eye Associates
Jacksonville, Florida, 32204
Eye Surgeons of CNY
Liverpool, New York, 13088
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Tulsa Ophthalmology
Tulsa, Oklahoma, 74104

Other trials in United States

Puerto Rico1 site

Centro Oftalmologico Metropolitano
San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)

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.

Read the detailed description

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 1 follow-up visit.

Conditions: Aphakia, Astigmatism, Presbyopia
Being tested: Clareon Vivity IOL - Non Toric, Clareon Vivity IOL - Toric, Clareon PanOptix Trifocal IOL - Non Toric, Clareon PanOptix Trifocal IOL - Toric
Keywords: Cataract surgery
Medical subject headings: Aphakia, Astigmatism, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clareon Vivity IOL - Non ToricDevice
Also called Models CNWET0, CCWET0
Spherical extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
Clareon Vivity IOL - ToricDevice
Also called Models CNWET2, CNWET3, CNWET4, CNWET5, CNWET6, CCWET-2, CCWET3, CCWET4, CCWET3, CCWET3-T6
Toric extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.
Clareon PanOptix Trifocal IOL - Non ToricDevice
Also called Model CNWTT0, CCWTT2
Spherical trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
Clareon PanOptix Trifocal IOL - ToricDevice
Also called Models CNWTT2, CNWTT3, CNWTT4, CNWTT5, CNWTT6, CCWTT2, CCWTT3, CCWTT4, CCWTT5, and CCWTT6
Toric trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.

Study groups in NCT05796453
Study group	Role	What they receive
Clareon Vivity IOL - Non Toric	Experimental	Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL. Receives: Device: Clareon Vivity IOL - Non Toric
Clareon Vivity IOL - Toric	Experimental	Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL. Receives: Device: Clareon Vivity IOL - Toric
Clareon PanOptix IOL - Non Toric	Experimental	Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL. Receives: Device: Clareon PanOptix Trifocal IOL - Non Toric
Clareon PanOptix IOL - Toric	Experimental	Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL. Receives: Device: Clareon PanOptix Trifocal IOL - Toric

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).
Measured: Up to Year 3
Number of Adverse Events
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following:
- Cystoid Macular Edema (CME)
- Hypopyon
- Endophthalmitis
- Lens dislocation
- Pupillary Block
- Retinal Detachment
- Secondary Surgical Interventions (Explantation/exchange/repositioning)
Measured: Up to Year 3
Number of Device Deficiencies
Device deficiencies will be assessed at each prospective visit. Examples include the following:
- Failure to meet product specifications (e.g., incorrect IOL power)
- IOL defect
- Broken IOL optic
- Broken IOL haptic
- Scratched IOL optic
- Unsealed device packaging
- Suspected product contamination
- Lack of performance
Measured: Up to Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 202321 Aug 2026

First posted3 Apr 2023
Study start19 Sep 2023
Primary completion21 Aug 2026
Study completion21 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AphakiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 470 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05796453
Sponsor's protocol ID: ILE632-I001
Status last verified: Aug 2026
First submitted: 22 Mar 2023
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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