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

NCT ID: NCT05518227

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2024-07-24

Brief Summary

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

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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Vivid Laser Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Baldassare, MD

Role: PRINCIPAL_INVESTIGATOR

Vivid Laser Center

Locations

Vivid Laser Center

Kelowna, British Columbia, Canada

Countries

Canada

Other Identifiers

RB-22-001

Identifier Type: -

Identifier Source: org_study_id