Clareon PanOptix for Cataract

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Argus Research Center, Inc.

Disqualifiers: Corneal pathology, Macular disease, Glaucoma, others

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

Compensation: Varies

Number of Visits: Unknown

290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the visual outcomes and satisfaction of individuals who have undergone cataract surgery with two types of intraocular lenses (IOLs). It examines the Clareon PanOptix lens against another multifocal lens to determine which offers better vision and satisfaction. The trial is ideal for adults who have had cataracts removed in both eyes and plan to receive these specific lenses. Participants should not have other eye conditions or a history of previous eye surgeries. As an unphased trial, this study provides a unique opportunity to contribute to understanding which lens yields better outcomes for future patients.

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 study team or your doctor.

What prior data suggests that these intraocular lenses are safe for cataract patients?

Research has shown that the Clareon PanOptix intraocular lens (IOL) is generally well-received by patients. Studies have found high satisfaction rates and few cases of bothersome serious vision changes. Most patients report stable and clear vision over time.

In contrast, similar multifocal IOLs have shown mixed results. While many patients are satisfied, some experience vision issues like haziness or blurriness. These problems affect less than half of the patients, but they are important to consider when choosing a lens.

Both treatments are considered safe, but they can affect vision quality and satisfaction differently. It's important to weigh the benefits against the possible side effects when considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Clareon PanOptix for cataracts because it uses advanced optics to potentially provide better vision at multiple distances. Unlike some traditional intraocular lenses (IOLs) that might focus on just one or two distances, Clareon PanOptix aims to improve vision for near, intermediate, and far distances all at once. Its unique design could reduce the need for glasses after cataract surgery, offering a more comprehensive solution for patients. Additionally, the material used in Clareon PanOptix is designed to enhance clarity and longevity, setting it apart from other multifocal IOLs currently available.

What evidence suggests that this trial's treatments could be effective for cataracts?

This trial will compare the Clareon PanOptix intraocular lens (IOL) with a similar multifocal IOL. Studies have shown that the Clareon PanOptix IOL provides excellent vision at close, middle, and far distances, with 94.09% of eyes achieving very good uncorrected near vision after one year. The lens remains stable, helping maintain clear vision. In contrast, similar multifocal IOLs offer better uncorrected near vision than traditional single-focus lenses and help more people avoid needing glasses. However, individuals with multifocal IOLs sometimes notice halos or glare more frequently. Overall, both options in this trial aim to improve vision after cataract surgery, with some differences in visual effects. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cataract surgery who need new intraocular lenses (IOLs). Participants should not have any other eye diseases that could affect the study's results. The specific eligibility criteria are not provided, so additional conditions may apply.

Inclusion Criteria

Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon

My condition is being compared in a study.

I am willing and able to sign the consent form.

Exclusion Criteria

I do not have any active eye infections or inflammation.

My study phase is Stage 1: IIT Pilot.

Participation in another clinical study that could interfere with the results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

Retrospective/prospective pilot phase to assess initial visual outcomes and patient satisfaction

4-6 weeks

Randomized Comparison Phase

Prospective, randomized comparison of visual outcomes and patient satisfaction between Clareon PanOptix and a comparable multifocal IOL

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clareon PanOptix
• Comparable multifocal IOL

Trial Overview The study compares visual outcomes and satisfaction between two types of IOLs: Clareon PanOptix or PanOptix Toric, and a similar multifocal lens. It includes both looking back at past patients and randomly assigning new ones to either lens type.

How Is the Trial Designed?

Group I: Comparable multifocal IOL Experimental Treatment 1 Intervention

Group II: Clareon PanOptix or PanOptix Toric IOLs Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Argus Research Center, Inc.

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9785155/

Visual and Refractive Efficacy of Panoptix Toric Intraocular ... In a real-world setting, the PanOptix toric trifocal IOL continues to demonstrate refractive accuracy and good visual performance at all focal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07161635

Post Market Clinical Evaluation of Clareon PanOptix Pro ... 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 ...

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

One-year outcomes of a trifocal intraocular lens with glistening ... At 12 months, 94.09% of eyes achieved UCNVA of LogMAR 0.1 or better. A slight mean hyperopic shift (+ 0.07D) was observed up to 12 months. Toric ...

4. myalcon.com myalcon.com/professional/insights/clareon-panoptix-pro-expert-perspectives/

Clareon®️ PanOptix®️ Pro: Surgeons Share Early Insights The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance ...

5. journals.lww.com journals.lww.com/jcrs/fulltext/2025/09000/rotational_stability,_centration,_and_patient.4.aspx

Rotational stability, centration, and patient satisfaction... The bilateral implantation of the Clareon PanOptix Toric IOL demonstrated excellent rotational stability, minimal decentration, and effective astigmatism ...

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

Clareon® Panoptix® IOL | Alcon Professional - MyAlcon Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.

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

The Clareon Vs AcrySof PanOptix Trifocal IOL Significantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected ...

8. alcon.com alcon.com/media-release/new-data-ascrs-highlight-alcon-innovations-optimize-patient-outcomes/

New Data at ASCRS Highlight Alcon Innovations that ... Studies on the PanOptix trifocal IOL showcase high patient satisfaction and low incidences of visual disturbances, especially severe ...

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

Expanding the Clareon ® IOL Family The three key characteristics that I would like to highlight about the Clareon® PanOptix® IOL are its stable visual outcomes over time, its ...