Visual Outcomes of Vivity in Patients With High Axial Length

Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length

The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Vivity

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C4K5
      • Image Plus Laser Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.

Description

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

Note: Ocular criteria must be met in both eyes.

Inclusion Criteria:

• Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
• Gender: Males and Females.
• Age: 50 years or older.
• 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.
• Motivated for greater degree of spectacle independence vs monofocal IOL.
• Axial length ≥24.5mm in both eyes.
• Planned cataract removal by femtosecond laser.

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.

• Ocular comorbidity that might hamper postoperative visual acuity.
• Previous refractive surgery.
• Irregular corneal astigmatism.
• Evidence of keratoconus as per Pentacam.
• Expected post-op VA worse than 20/25 (Snellen).
• Refractive lens exchange.
• Difficulties comprehending written or spoken English language.
• Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
• Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
• Axial length <24.5mm.
• Evidence of macular pathology as per optical coherence tomography examination.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral implantation of the Vivity IOL; Vivity intraocular lens (IOL)	Device: Vivity; Vivity intraocular lens (IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Distance Visual Acuity (logMAR)	Binocular uncorrected distance visual acuity (logMAR)	3 months postoperatively
Binocular Uncorrected Intermediate Visual Acuity (logMAR)	Binocular uncorrected intermediate visual acuity (logMAR)	3 months postoperatively
Binocular Uncorrected Near Visual Acuity (logMAR)	Binocular uncorrected near visual acuity (logMAR)	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction Error	Percentage of eyes with absolute prediction error of 0.5D or less	3 months postoperatively
Binocular Corrected Distance Visual Acuity (logMAR)	Binocular corrected distance visual acuity (logMAR)	3 months postoperatively
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)	Binocular distance corrected intermediate visual acuity (logMAR)	3 months postoperatively
Binocular Distance Corrected Near Visual Acuity (logMAR)	Binocular distance corrected near visual acuity (logMAR)	3 months postoperatively
Monocular Corrected Distance Visual Acuity (logMAR)	Monocular corrected distance visual acuity (logMAR)	3 months postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)	Monocular distance corrected intermediate visual acuity (logMAR)	3 months postoperatively
Monocular Distance Corrected Near Visual Acuity (logMAR)	Monocular distance corrected near visual acuity (logMAR)	3 months postoperatively
Manifest Refraction Spherical Equivalent	Manifest refraction spherical equivalent	3 months postoperatively
Questionnaire	Questionnaire for visual disturbance scores (QUVID)	3 months postoperatively
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)	Binocular distance-corrected low contrast distance visual acuity (logMAR)	3 months postoperatively
Percentage of Participants With Spectacle Independence	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.	3 months

Collaborators and Investigators

• Sponsor: Dr. James J. Wiens Medical Corporation
• Collaborators: Sengi
• Investigators: Principal Investigator: James J Wiens, MD, Dr. James J. Wiens Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: EDOF IOL Vivity
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JW-21-001

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