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Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

NCT04224155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-10-10

Study results available
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Summary

The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.

Conditions

  • Cataract

Interventions

DEVICE

enVista MX60EFH trifocal intraocular lenses (IOLs)

enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally

DEVICE

enVista MX60E monofocal intraocular lenses (IOLs)

enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Anya Loncaric · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-06-14
Completion
2022-06-14
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224155 on ClinicalTrials.gov