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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518227
• Other study ID #: RB-22-001
• Status: Recruiting
• Start date: January 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Vivid Laser Center
• Contact: Sukey Hanson
• Phone: 250-979-2088
• Email: cataracts[@]vividlaser.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• The Clareon™ PanOptix™ Trifocal (toric and non-toric models)
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

Locations

Country	Name	City	State
Canada	Vivid Laser Center	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Vivid Laser Center	Sengi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Binocular distance corrected intermediate visual acuity (33 cm)		3 months postoperative
Other	Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Primary	Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative
Secondary	Binocular uncorrected distance visual acuity (6m)		3 months postoperative
Secondary	Binocular uncorrected intermediate visual acuity (60 cm)		3 months postoperative
Secondary	Binocular uncorrected near visual acuity (40 cm)		3 months postoperative
Secondary	Binocular corrected distance visual acuity (6m)		3 months postoperative
Secondary	Binocular distance corrected intermediate visual acuity (60 cm)		3 months postoperative
Secondary	Binocular distance corrected intermediate visual acuity (40 cm)		3 months postoperative
Secondary	Manifest refraction		3 months postoperative
Secondary	Spectacle independence	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative