Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens

To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models)

Detailed Description

This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5Y7
      • Vivid Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate, and distance vision, and who are considered appropriate candidates for trifocal lens implantation.

Description

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric).
• Visually significant cataracts bilaterally.
• History of successful soft multifocal contact lens use in the past (within ≤ last 5 years).
• Healthy ocular exam.
• Gender: Males and Females.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Previous monovision patients.
• Ocular comorbidity that might hamper post operative visual acuity (Uveitis, Keratoconus, Retinopathies, Glaucoma).
• Previous ocular or refractive surgery.
• Expected monocular post-op distance VA worse than 20/25 (Snellen) in either eye.
• Refractive lens exchange.
• Angle kappa measurement in a single eye over 0.6 mm.
• Irregular corneal astigmatism or ectasia.
• Difficulties comprehending written or spoken English language.
• Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
• Severe/uncontrolled Ocular surface disease/Dry Eye Disease.
• Intraoperative complications during procedure.
• Visual expectations exceed outcomes.
• Strabismus (with or without amblyopia).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The Clareon™ PanOptix™ Trifocal (toric and non-toric models); Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)	Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models); Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected distance visual acuity (6m)		3 months postoperative
Binocular uncorrected intermediate visual acuity (60 cm)		3 months postoperative
Binocular uncorrected near visual acuity (40 cm)		3 months postoperative
Binocular corrected distance visual acuity (6m)		3 months postoperative
Binocular distance corrected intermediate visual acuity (60 cm)		3 months postoperative
Binocular distance corrected intermediate visual acuity (40 cm)		3 months postoperative
Manifest refraction		3 months postoperative
Spectacle independence	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Binocular distance corrected intermediate visual acuity (33 cm)		3 months postoperative

Collaborators and Investigators

• Sponsor: Vivid Laser Center
• Collaborators: Sengi
• Investigators: Principal Investigator: Ronald Baldassare, MD, Vivid Laser Center

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RB-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes