Visual Outcomes of Vivity in Patients With High Axial Length

NCT ID: NCT05210569

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2023-09-06

Brief Summary

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.

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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral implantation of the Vivity IOL

Vivity intraocular lens (IOL)

Vivity

Intervention Type: DEVICE

Vivity intraocular lens (IOL)

Interventions

Vivity

Vivity intraocular lens (IOL)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Note: Ocular criteria must be met in both eyes.

• 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

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Dr. James J. Wiens Medical Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James J Wiens, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. James J. Wiens Medical Corporation

Locations

Image Plus Laser Eye Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JW-21-001

Identifier Type: -

Identifier Source: org_study_id