Visual Outcomes of Vivity in Patients With High Axial Length

NCT05210569 | Completed Results FDA Device

• 1 other identifier: JW-21-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

EDOF IOL Vivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Prediction Error

  3 months postoperatively

• Binocular Corrected Distance Visual Acuity (logMAR)

  3 months postoperatively

• Binocular Distance Corrected Intermediate Visual Acuity (logMAR)

  3 months postoperatively

• Binocular Distance Corrected Near Visual Acuity (logMAR)

  3 months postoperatively

• Monocular Corrected Distance Visual Acuity (logMAR)

  3 months postoperatively

Study Arms (1)

Bilateral implantation of the Vivity IOL

Vivity intraocular lens (IOL)

Device: Vivity

Interventions

Vivity DEVICE

Vivity intraocular lens (IOL)

Bilateral implantation of the Vivity IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. James J. Wiens Medical Corporation: lead
• Sengi: collaborator

Study Sites (1)

Image Plus Laser Eye Centre

Winnipeg, Manitoba, R3C4K5, Canada

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr James Wiens
• Organization: Image Plus Laser Eye Centre

jamesjwiens@gmail.com

1-204-943-6287

Study Officials

• James J Wiens, MD

  Dr. James J. Wiens Medical Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 13, 2022
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: March 11, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)