Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month 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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

• Study Contact: Name: Sheryl Gardener; Phone Number: 250-615-5002; Email: sjulseth1@hotmail.com

Study Locations

• Canada
  • British Columbia
    • Terrace, British Columbia, Canada, V8G 1V7
      • Vision North Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.

Description

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Visually significant age-related cataracts bilaterally.
• Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
• 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.
• Clear intraocular media other than cataract.
• Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
• IOL powers between 6D and 30D, T2-T6.

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 ocular or refractive surgery
• Ocular surface disease/Dry Eye Disease
• Intraoperative complications during procedure
• Glaucoma, including well-controlled
• Any disorders that reduce binocular vision (ie Strabismus)
• Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon Vivity extended depth of focus (EDOF) intraocular lens; Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens	Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens; Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular distance-corrected visual acuity at distance (6m)	3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of eyes with absolute prediction error less than or equal to 0.50D	3 months postoperative
Percentage of eyes with refractive astigmatism less than or equal to 0.50 D	3 months postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative
Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Binocular uncorrected and distance-corrected visual acuity at near (40cm)		3 months postoperative

Collaborators and Investigators

• Sponsor: Thomas Nagy
• Collaborators: Sengi
• Investigators: Principal Investigator: Thomas Nagy, MD, Vision North Eye Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TN-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes