search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
enVista MX60E
enVista MX60EF
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bausch Site 108
  • Bausch Site 113
  • Bausch Site 120
  • Bausch Site 115
  • Bausch Site 103
  • Bausch Site 107
  • Bausch Site 117
  • Bausch Site 101
  • Bausch Site 119
  • Bausch Site 102
  • Bausch Site 124
  • Bausch Site 118
  • Bausch Site 106
  • Bausch Site 109
  • Bausch Site 116
  • Bausch Site 121
  • Bausch Site 112
  • Bausch Site 110
  • Bausch Site 104
  • Bausch Site 105
  • Bausch Site 111
  • Bausch Site 122
  • Bausch Site 123

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enVista MX60EF

enVista MX60E

Arm Description

enVista MX60EF (trifocal) multifocal IOL (MIOL)

enVista MX60E monofocal IOL

Outcomes

Primary Outcome Measures

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)
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)
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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2018
Last Updated
October 23, 2023
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT03603600
Brief Title
Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Approximately 334 subjects will be implanted bilaterally with the enVista MX60EF trifocal MIOL, and approximately 167 control subjects will be implanted bilaterally with the enVista MX60E monofocal IOL
Masking
ParticipantOutcomes Assessor
Masking Description
The Investigator implanting the IOL and designated site personnel will be unmasked to the assignment of IOLs. Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned.
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enVista MX60EF
Arm Type
Experimental
Arm Description
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Arm Title
enVista MX60E
Arm Type
Active Comparator
Arm Description
enVista MX60E monofocal IOL
Intervention Type
Device
Intervention Name(s)
enVista MX60E
Intervention Description
enVista MX60E monofocal IOL
Intervention Type
Device
Intervention Name(s)
enVista MX60EF
Intervention Description
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Primary Outcome Measure Information:
Title
Photopic monocular best-corrected distance visual acuity (BCDVA)
Description
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)
Time Frame
Day 120 to Day 180 after second eye implantation
Title
Photopic monocular distance-corrected near visual acuity (DCNVA)
Description
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)
Time Frame
Day 120 to Day 180 after second eye implantation
Title
Photopic monocular distance-corrected intermediate visual acuity (DCIVA)
Description
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
Time Frame
Day 120 to Day 180 after second eye implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed. 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. 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. 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. Subjects must have clear intraocular media other than the cataract in both eyes. Exclusion Criteria: 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. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. 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. Subjects who have uncontrolled glaucoma in either eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anya Loncaric
Organizational Affiliation
Bausch health companies
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 108
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Bausch Site 113
City
Garden Grove
State/Province
California
ZIP/Postal Code
02843
Country
United States
Facility Name
Bausch Site 120
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Bausch Site 115
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
Bausch Site 103
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Bausch Site 107
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Bausch Site 117
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Bausch Site 101
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Bausch Site 119
City
Birmingham
State/Province
Mississippi
ZIP/Postal Code
49009
Country
United States
Facility Name
Bausch Site 102
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Bausch Site 124
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Facility Name
Bausch Site 118
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Bausch Site 106
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Bausch Site 109
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Bausch Site 116
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Bausch Site 121
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Bausch Site 112
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Bausch Site 110
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Bausch Site 104
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Bausch Site 105
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Bausch Site 111
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Bausch Site 122
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Bausch Site 123
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs