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CataractNCT03603600

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

A study testing enVista MX60E and enVista MX60EF in people with Cataract, run by Bausch & Lomb Incorporated at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
enVista MX60E and enVista MX60EF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
23 sitesUnited States
Study dates
31 May 2018to 4 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
  • 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.

Who cannot join

  • 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.
  • 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.
  • Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
  • Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
Show all 19Show fewer
  • Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
  • 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).
  • Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
  • 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.
  • Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
  • Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
  • 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).
  • Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
  • Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
  • 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.
  • 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.
  • 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.
  • 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).

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Bausch Site 119

    Birmingham, Mississippi, 49009

  • Bausch Site 101

    Bloomington, Minnesota, 55420

  • Bausch Site 106

    Brecksville, Ohio, 44141

  • Bausch Site 104

    Cedar Park, Texas, 78613

  • Bausch Site 109

    Columbus, Ohio, 43215

  • Bausch Site 105

    Dallas, Texas, 75243

  • Bausch Site 108

    Fayetteville, Arkansas, 72703

  • Bausch Site 113

    Garden Grove, California, 02843

  • Bausch Site 111

    Houston, Texas, 77008

  • Bausch Site 117

    Lake Villa, Illinois, 60046

  • Bausch Site 118

    Las Vegas, Nevada, 89145

  • Bausch Site 112

    Memphis, Tennessee, 38119

  • Bausch Site 107

    Mt. Dora, Florida, 32757

  • Bausch Site 110

    Nashville, Tennessee, 37205

  • Bausch Site 120

    Northridge, California, 91325

  • Bausch Site 124

    Omaha, Nebraska, 68137

  • Bausch Site 116

    Pittsburgh, Pennsylvania, 16066

  • Bausch Site 115

    Redding, California, 96002

  • Bausch Site 122

    San Antonio, Texas, 78215

  • Bausch Site 123

    San Antonio, Texas, 78229

  • Bausch Site 121

    Sioux Falls, South Dakota, 57108

  • Bausch Site 102

    St Louis, Missouri, 63131

  • Bausch Site 103

    Torrance, California, 90505

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Cataract
Being tested
enVista MX60E, enVista MX60EF
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enVista MX60EDevice

    enVista MX60E monofocal IOL

  • enVista MX60EFDevice

    enVista MX60EF (trifocal) multifocal IOL (MIOL)

Study groups in NCT03603600
Study groupRoleWhat they receive
enVista MX60EFExperimentalenVista MX60EF (trifocal) multifocal IOL (MIOL)
Receives: Device: enVista MX60EF
enVista MX60EActive comparatorenVista MX60E monofocal IOL
Receives: Device: enVista MX60E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  2. 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)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  3. 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

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  4. Serious Adverse Events

    All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit

    Measured: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

  5. The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit

    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.

    Measured: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

  6. The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint

    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

    Measured: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

Secondary outcomes (7)

  1. Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4

    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)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  2. Photopic Binocular UNVA at 40 cm at Postoperative Visit 4

    Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  3. Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4

    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)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  4. Photopic Binocular UIVA at 66 cm at Postoperative Visit 4

    Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)

    Measured: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  5. First-eye BCDVA Evaluated at Postoperative Visit 5

    First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Measured: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

  6. First-eye DCNVA Evaluated at Postoperative Visit 5

    First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Measured: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

  7. First-eye DCIVA Evaluated at Postoperative Visit 5

    First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Measured: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start31 May 2018
  3. Primary completion4 May 2023
  4. Study completion4 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603600
Sponsor's protocol ID
945
Status last verified
Dec 2024
First submitted
18 Jul 2018
Last updated
24 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing enVista MX60E and enVista MX60EF in people with Cataract, run by Bausch & Lomb Incorporated at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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