NCT06333015

Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

A Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes.

Detailed description

The study will evaluate the safety and effectiveness of the enVista Beyond (EY) EDF IOL in providing increased depth of focus, comparable distance and improved near and intermediate visual acuity compared to the parent enVista monofocal IOL. This is a prospective, multicenter, randomized, controlled, subject and visual acuity assessor masked, parallel-group study in subjects bilaterally implanted with either EY or enVista MX60E monofocal IOL following cataract surgery.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	enVista Beyond EY (EDF) IOL	enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
DEVICE	enVista MX60E monofocal IOL	enVista MX60E monofocal IOL

Timeline

• Start date: 2024-08-07
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-03-27
• Last updated: 2025-11-19

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study