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

December 12, 2024 updated by: Bausch & Lomb Incorporated

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
501

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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.
  6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear.
  7. Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
  8. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.

Exclusion Criteria:

  1. Subjects who have used an investigational drug or device 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.
  5. Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
  6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
  7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
  8. Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the study (refer to the relevant attachment of the Study Reference Manual).
  9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
  10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/100 or worse in either eye.
  11. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
  12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
  13. Subjects who have a preoperative corneal astigmatism > 1.0 D in either eye, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
  14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
  15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
  16. Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Investigator.
  17. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study.
  18. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study.
  19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
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, up to 210 days from first eye implantation at Baseline.
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
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, up to 210 days from first eye implantation at Baseline.
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
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, up to 210 days from first eye implantation at Baseline.
Serious Adverse Events
Time Frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
Time Frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
Time Frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic binocular distance-corrected near visual acuity (DCNVA) 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, up to 210 days from first eye implantation at Baseline.
Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic binocular uncorrected near visual acuity (UNVA) 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, up to 210 days from first eye implantation at Baseline.
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic binocular distance-corrected intermediate visual acuity (DCIVA) 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, up to 210 days from first eye implantation at Baseline.
Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
Time Frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
First-eye BCDVA Evaluated at Postoperative Visit 5
Time Frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCNVA Evaluated at Postoperative Visit 5
Time Frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCIVA Evaluated at Postoperative Visit 5
Time Frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch & Lomb Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rosangela Nolasco, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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