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

Vivid Laser Center1 site in 1 country12 target enrollmentJanuary 19, 2023

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Vivid Laser Center
Enrollment: 12
Locations: 1
Primary Endpoint: Satisfaction questionnaire
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 19, 2023

End Date

July 24, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Vivid Laser Center

Responsible Party

Sponsor

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

•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).

Outcomes

Primary Outcomes

Satisfaction questionnaire

Time Frame: 3 months postoperative

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

Secondary Outcomes

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)
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)