IOL Implants for Vision Improvement

Not currently recruiting at 7 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Other study, Corneal surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the long-term effectiveness of certain lens implants in improving vision. Specifically, it examines Clareon Vivity and PanOptix lenses, types of intraocular lenses (IOLs), in individuals who received them in both eyes a few months ago. It is ideal for those who had these specific lenses implanted in both eyes within the last 3-6 months and have a documented history of eye issues. By joining, participants assist researchers in understanding the safety and performance of these lenses. As an unphased trial, this study allows participants to contribute to valuable research that could enhance vision care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these IOL implants are safe for vision improvement?

Research has shown that the Clareon PanOptix and Clareon Vivity lenses are generally well-received by patients. The Clareon PanOptix lens, which aids in seeing at different distances, provides good vision with few issues like glare or halos, common with some other lenses.

For the Clareon Vivity lens, studies suggest it offers clear vision at various distances with even fewer side effects. This lens provides a wider range of vision without the usual problems associated with lenses that assist with multiple distances, such as visual disturbances. These lenses have a strong safety record, having passed the necessary tests for approval and use in the eye.

Overall, these lenses have demonstrated promising results in terms of safety and effectiveness in improving vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clareon PanOptix and Clareon Vivity intraocular lenses (IOLs) because they offer innovative ways to improve vision after cataract surgery. Unlike standard monofocal lenses that only enhance vision at one distance, the Clareon PanOptix Trifocal IOL provides clear vision across multiple distances, which can reduce the need for glasses. The Clareon Vivity IOL, on the other hand, uses a non-diffractive technology to extend the range of vision, offering a smoother transition between near and distant vision without some of the side effects associated with traditional multifocal lenses. Additionally, the toric versions of these lenses are designed to correct astigmatism, making them versatile solutions for various vision correction needs.

What is the effectiveness track record for Clareon Vivity and PanOptix IOLs in vision improvement?

This trial will compare different IOL implants for vision improvement. Research has shown that the Clareon PanOptix Trifocal IOL, which participants in this trial may receive, significantly improves vision quality and reduces the need for glasses. Studies have found it enhances vision at various distances, with many patients feeling satisfied and experiencing fewer side effects. Similarly, the Clareon PanOptix Trifocal Toric IOL, another option in this trial, effectively provides clear and stable vision for people with astigmatism.

For the Clareon Vivity IOL, also studied in this trial, research highlights its ability to improve focus, enhancing both distance and middle-range vision. It helps reduce the need for reading glasses, although there might be a slight decrease in contrast compared to standard lenses. The Clareon Vivity Toric IOL, another treatment arm in this trial, offers similar benefits for those with astigmatism, providing clear and lasting vision improvements. ^{1 4 6 7 8}

Who Is on the Research Team?

Clinical Trial Lead, Surgical

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This study is for people who have had bilateral implantation of Clareon Vivity or PanOptix lenses, with or without astigmatism correction (Toric), between 3-6 months ago. Participants must be able to sign a consent form and have their medical history available. Pregnant individuals, those in other studies, or those who've had corneal surgery after lens implantation cannot join.

Inclusion Criteria

Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection

Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form

I had specific lens implants in both eyes 3-6 months ago.

Exclusion Criteria

Subject is pregnant at the time of enrollment

Other protocol-defined exclusion criteria may apply

Subject is currently participating in another investigational drug or device study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment.

3-6 months

Prospective Follow-up

Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

Up to 3 years

Regular visits up to Year 3

Long-term Follow-up

Participants are monitored for safety and performance of the IOLs over a long-term period.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Clareon PanOptix Trifocal IOL - Non Toric
• Clareon PanOptix Trifocal IOL - Toric
• Clareon Vivity IOL - Non Toric
• Clareon Vivity IOL - Toric

Trial Overview

The trial aims to assess the long-term safety and effectiveness of two types of intraocular lenses: Clareon Vivity and PanOptix, including versions designed for astigmatism (Toric). It's a follow-up study focusing on patients who already received these implants.

How Is the Trial Designed?

Group I: Clareon Vivity IOL - Toric Experimental Treatment 1 Intervention

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.

Group II: Clareon Vivity IOL - Non Toric Experimental Treatment 1 Intervention

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.

Group III: Clareon PanOptix IOL - Toric Experimental Treatment 1 Intervention

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.

Group IV: Clareon PanOptix IOL - Non Toric Experimental Treatment 1 Intervention

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.

Clareon PanOptix Trifocal IOL - Non Toric is already approved in United States, European Union for the following indications:

Approved in United States as AcrySof IQ Clareon PanOptix Trifocal IOL for:

• Visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed

Approved in European Union as Clareon PanOptix Trifocal IOL for:

• Visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

In a study of 30 patients undergoing combined 23-gauge microincisional vitrectomy and cataract surgery, the AcrySof toric intraocular lens (IOL) significantly improved uncorrected visual acuity compared to the non-toric IOL at 1, 3, and 6 months post-surgery.

The toric IOL group also had a lower mean absolute residual refractive cylinder, indicating better astigmatism correction, while demonstrating good rotational stability, with 66.7% of lenses remaining within 5° of their intended axis after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. Park, DH., Shin, JP., Kim, SY.[2022]

In a study involving 71 patients who received bilateral implantation of either the PanOptix or Trinova trifocal intraocular lenses, the PanOptix IOL demonstrated significantly better intermediate and near visual acuity compared to the Trinova IOL at a 3-month follow-up.

Both IOLs were found to be safe, with no adverse events reported, making the PanOptix IOL a strong option for patients looking to reduce their dependence on glasses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Visual Outcomes of Two Trifocal IOLs. Kılıç, A., Özpınar, A., Tanrıverdi, C.[2023]

The AcrySof IQ PanOptix IOL offers a more natural intermediate focal point of 60 cm, enhancing comfort for tasks like using computers, compared to traditional trifocal IOLs with an 80 cm focal point.

Clinical evidence from 12 studies indicates that the PanOptix IOL provides good visual outcomes and high spectacle independence, similar to other multifocal and extended depth of focus IOLs, but individual patient needs must be considered for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. Sudhir, RR., Dey, A., Bhattacharrya, S., et al.[2019]

In a study involving 19 eyes from 14 patients with significant preoperative corneal astigmatism (average 4.00 D), high-cylinder power AcrySof toric intraocular lenses (IOLs) effectively reduced residual astigmatism to an average of 0.55 D three months after surgery.

The uncorrected distance visual acuity improved significantly from an average of 1.3 logMAR preoperatively to 0.11 logMAR postoperatively, demonstrating the IOLs' efficacy in enhancing vision after cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. Cervantes-Coste, G., Garcia-Ramirez, L., Mendoza-Schuster, E., et al.[2012]

In a study of 100 eyes from 56 patients, the AcrySof SN60TT toric intraocular lens (IOL) showed comparable higher-order aberrations (HOAs) and optical quality to the non-toric AcrySof SN60AT IOL one year after surgery.

The toric IOL effectively corrected corneal astigmatism with a low residual refractive astigmatism of 0.44 D, indicating stable postoperative alignment and good optical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo assessment of higher-order aberrations after AcrySof toric intraocular lens implantation: a comparative study. Scialdone, A., Raimondi, G., Monaco, G.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11495208/

The Clareon Vs AcrySof PanOptix Trifocal IOL

The Clareon PanOptix trifocal lens provides similar satisfaction and spectacle independence and has a similar side effect profile and BCVA outcome.

2.

myalcon.com

myalcon.com/professional/cataract-surgery/iols/clareon-panoptix/

Clareon® Panoptix® IOL | Alcon Professional - MyAlcon

The Clareon® PanOptix® IOL is the first available trifocal lens in the US. Learn the features and see how it may assist patients with vision ...

3.

bmcophthalmol.biomedcentral.com

bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-025-04198-2

One-year outcomes of a trifocal intraocular lens with glistening ...

The new hydrophobic acrylic trifocal IOL (CNWT) with HEMA demonstrated significant improvements in visual acuity and stable refractive outcomes over one year ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S000293942500131X

Comparison of Two-Year Clinical and Patient-Reported ...

Clareon PanOptix outperformed Acrysof IQ PanOptix in visual quality and spectacle-independent visual function, potentially resulting from a lower prevalence of ...

5.

journals.lww.com

journals.lww.com/jcrs/fulltext/2025/09000/visual_performance_after_implantation_of_a_new.6.aspx

Visual performance after implantation of a new trifocal...

The primary efficacy and safety endpoint of this study were to evaluate monocular corrected distance visual acuity (CDVA) and the presence of IOL glistenings 12 ...

6.

myalcon.com

myalcon.com/professional/cataract-surgery/iols/clareon-panoptix-pro/

Clareon® PanOptix® Pro Trifocal IOL - MyAlcon

Discover Clareon® PanOptix® Pro with ENLIGHTEN® NXT, featuring 94% light utilization, less scatter, and better contrast for greater spectacle independence.

7.

crstoday.com

crstoday.com/articles/expanding-the-clareon-iol-family/expanding-the-clareon-iol-family

Expanding the Clareon ® IOL Family

I recently completed a comparison study of the AcrySof® IQ PanOptix® and the Clareon® PanOptix® IOLs in approximately 200 eyes (unpublished data) ...

8.

bestcataractsurgeons.com

bestcataractsurgeons.com/panoptix-lens-review/

A Complete Guide to the PanOptix IOL

The PanOptix is one of the most popular advanced technology lens implants in the world. So many patients have achieved complete freedom from glasses.