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Completed

NCT Number: NCT05346172

The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard Eye Associates, Laguna Hills, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PanOptix or PanOptix Toric IOL

Device

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

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?"

    Time frame: Up to 6 months

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

Secondary outcomes

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

    Time frame: Up to 6 months

    How often do you need glasses to see the computer.

  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)?"

    Time frame: Up to 6 months

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

Other outcomes

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

    Time frame: Up to 6 months

    Percentage of patients satisfied with their vision after surgery

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

    Time frame: Up to 6 months

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

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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