NCT05210569

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Dr. James J. Wiens Medical Corporation · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DEVICE	Vivity	Vivity intraocular lens (IOL)

Timeline

• Start date: 2022-01-13
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2022-01-27
• Last updated: 2025-03-11
• Results posted: 2025-02-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study