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The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

The Clareon PanOptix Trifocal IOL: A Study of Patient Satisfaction and Visual Performance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05346172
Enrollment
60
Registered
2022-04-26
Start date
2022-06-17
Completion date
2023-03-10
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Panoptix or Panoptix Toric implant.

Detailed description

The PanOptix trifocal lens by Alcon was introduced in 2015 and is currently in use in over 70 countries. Its outcomes on the AcrySof platform are well documented and highly appealing to patients and clinicians.,, Clinicians no longer need to routinely target monovision or modified monovision to provide a range of vision. With the release of the Clareon material for this lens, questions remain about how the new lens material will influence patient satisfaction and uncorrected visual performance.

Interventions

DEVICEPanOptix or PanOptix Toric IOL

Patients who previously underwent cataract surgery with the PanOptix or PanOptix Toric IOL in both eyes.

Sponsors

Research Insight LLC
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures. * Patients implanted with Clareon PanOptix or Clareon Panoptix Toric lenses bilaterally within 6 months of the survey administration.

Exclusion criteria

* Patients with visually significant comorbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery * Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) * Patients with previous refractive surgery within the past 6 months prior to cataract surgery * Patients with \> grade 1 posterior capsule opacity at their last visit

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients reporting not at all or just a little when asked, With or without glasses, how much do you notice glare or haloes around lights in dim light situations?Up to 6 monthsPercentage of patients who notice glare or haloes around lights in dim light situations

Secondary

MeasureTime frameDescription
Percentage of postoperative patients who report rarely when asked How often do you need glasses to see the computer?Up to 6 monthsHow often do you need glasses to see the computer.
Percentage of postop patients who report they do not require reading glasses for various activities when asked For what types of activities do you need glasses to see (other than sunglasses)?Up to 6 monthsPercentage of postoperative patients who report that they do not require glasses for varous activities.

Other

MeasureTime frameDescription
Percentage of patients reporting very satisfied when asked, Overall, how satisfied are you with your vision after your latest surgery?Up to 6 monthsPercentage of patients satisfied with their vision after surgery
Percentage of patients who report very satisfied or Somewhat satisfied to the same question.Up to 6 monthsPercentage of patients who report very satisfied or Somewhat satisfied to the same question.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026