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CompletedNCT05346172Updated Mar 15, 2023

The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

An observational study in Cataract, sponsored by Research Insight LLC. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Research Insight LLC · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 60 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Research Insight LLC is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients undergoing cataract surgery.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • DevicePanOptix or PanOptix Toric IOL

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

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What researchers measure

Primary outcomes

  1. 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?"

    Percentage of patients who notice glare or haloes around lights in dim light situations

    Time frame: Up to 6 months

Secondary outcomes

  1. Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"

    How often do you need glasses to see the computer.

    Time frame: Up to 6 months

  2. 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)?"

    Percentage of postoperative patients who report that they do not require glasses for varous activities.

    Time frame: Up to 6 months

Other outcomes

  1. Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"

    Percentage of patients satisfied with their vision after surgery

    Time frame: Up to 6 months

  2. Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.

    Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.

    Time frame: Up to 6 months

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Study locations

3 sites
  • Harvard Eye Associates
    Laguna Hills, California 92653, United States
  • Florida Vision Institute
    Stuart, Florida 34994, United States
  • IllinEye Consulting
    Evansville, Illinois 62025, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05346172
Lead sponsor
Research Insight LLC
Responsible party
Sponsor
First posted
Apr 26, 2022
Start date
Jun 17, 2022
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023
Last update
Mar 15, 2023

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 Mar 2023. You cannot join it, but the record below documents what was studied.

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