NCT05488769

Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Thomas Nagy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

Detailed description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity 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), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Clareon Vivity extended depth of focus (EDOF) intraocular lens	Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Timeline

• Start date: 2022-08-25
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-08-05
• Last updated: 2023-01-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study