The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: PanOptix or PanOptix Toric IOL

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: John Hovanesian, MD; Phone Number: 9497423937; Email: jhovanesian@researchinsightca.com
• Study Contact Backup: Name: Leslie Lemieux, BS; Phone Number: 9513884422; Email: research@researchinsightca.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cataract surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
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.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 6 months
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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Research Insight LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2111 Clareon PanOptix

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes