The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

Completed

• Conditions: Cataract

• Registration Number: NCT05346172
• Lead Sponsor: Research Insight LLC

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.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Study Start: 2022-06-17
• Status Verified: 2023-03
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 months	Percentage of patients who notice glare or haloes around lights in dim light situations

Secondary Outcome Measures

Name	Time	Method
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"	Up to 6 months	How 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 months	Percentage of postoperative patients who report that they do not require glasses for varous activities.

Trial Locations

Locations (3)

IllinEye Consulting; 🇺🇸 Evansville, Illinois, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Florida Vision Institute; 🇺🇸 Stuart, Florida, United States