NCT04482439

Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Newsom Eye & Laser Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

Detailed description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Vivity Extended Depth of Focus intraocular lens (IOL)	Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.

Timeline

• Start date: 2020-07-17
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2020-07-22
• Last updated: 2022-03-03
• Results posted: 2022-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study