Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens

A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: enVista MX60EF; Device: enVista MX60E

Detailed Description

Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Bausch Site 108
  • California
    • Garden Grove, California, United States, 02843
      • Bausch Site 113
    • Northridge, California, United States, 91325
      • Bausch Site 120
    • Redding, California, United States, 96002
      • Bausch Site 115
    • Torrance, California, United States, 90505
      • Bausch Site 103
  • Florida
    • Mount Dora, Florida, United States, 32757
      • Bausch Site 107
  • Illinois
    • Lake Villa, Illinois, United States, 60046
      • Bausch Site 117
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Bausch Site 101
  • Mississippi
    • Birmingham, Mississippi, United States, 49009
      • Bausch Site 119
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Bausch Site 102
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Bausch Site 124
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Bausch Site 118
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Bausch Site 106
    • Columbus, Ohio, United States, 43215
      • Bausch Site 109
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 16066
      • Bausch Site 116
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Bausch Site 121
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Bausch Site 112
    • Nashville, Tennessee, United States, 37205
      • Bausch Site 110
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Bausch Site 104
    • Dallas, Texas, United States, 75243
      • Bausch Site 105
    • Houston, Texas, United States, 77008
      • Bausch Site 111
    • San Antonio, Texas, United States, 78215
      • Bausch Site 122
    • San Antonio, Texas, United States, 78229
      • Bausch Site 123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.
5. Subjects must have clear intraocular media other than the cataract in both eyes.

Exclusion Criteria:

1. Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye.
3. Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
4. Subjects who have uncontrolled glaucoma in either eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enVista MX60EF; enVista MX60EF (trifocal) multifocal IOL (MIOL)	Device: enVista MX60EF; enVista MX60EF (trifocal) multifocal IOL (MIOL)
Active Comparator: enVista MX60E; enVista MX60E monofocal IOL	Device: enVista MX60E; enVista MX60E monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photopic monocular best-corrected distance visual acuity (BCDVA)	Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)	Day 120 to Day 180 after second eye implantation
Photopic monocular distance-corrected near visual acuity (DCNVA)	Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)	Day 120 to Day 180 after second eye implantation
Photopic monocular distance-corrected intermediate visual acuity (DCIVA)	Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation	Day 120 to Day 180 after second eye implantation

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Anya Loncaric, Bausch health companies

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No