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

Terminated

• Conditions: Cataract
• Interventions: Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models)

• Registration Number: NCT05518227
• Lead Sponsor: Vivid Laser Center

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.

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2023-01-19
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Clareon™ PanOptix™ Trifocal (toric and non-toric models)	The Clareon™ PanOptix™ Trifocal (toric and non-toric models)	Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

Primary Outcome Measures

Name	Time	Method
Satisfaction questionnaire	3 months postoperative	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.

Secondary Outcome Measures

Name	Time	Method
Binocular uncorrected distance visual acuity (6m)	3 months postoperative
Binocular uncorrected 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	3 months postoperative	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
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

Trial Locations

Locations (1)

Vivid Laser Center; 🇨🇦 Kelowna, British Columbia, Canada