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

Vivid Laser Center

Status

Terminated

Conditions

Cataract

Treatments

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

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05518227

RB-22-001

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

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.