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

NCT05518227 | Terminated FDA Device

• 1 other identifier: RB-22-001
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Satisfaction questionnaire

  The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.

  3 months postoperative

Secondary Outcomes (8)

• 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

Other Outcomes (2)

• Binocular distance corrected intermediate visual acuity (33 cm)

  3 months postoperative

• Visual disturbances questionnaire

  3 months postoperative

Study Arms (1)

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)

Interventions

The Clareon™ PanOptix™ Trifocal (toric and non-toric models) DEVICE

Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

The Clareon™ PanOptix™ Trifocal (toric and non-toric models)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivid Laser Center: lead
• Sengi: collaborator

Study Sites (1)

Vivid Laser Center

Kelowna, British Columbia, V1Y 5Y7, Canada

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ronald Baldassare, MD

  Vivid Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 19, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)