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CataractNCT04224155

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

A study testing enVista MX60EFH trifocal intraocular lenses (IOLs) and enVista MX60E monofocal intraocular lenses (IOLs) in people with Cataract, run by Bausch & Lomb Incorporated at 9 sites in Canada.

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 performance of the enVista trifocal intraocular lens when implanted in the capsular bag. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
enVista MX60EFH trifocal intraocular lenses (IOLs) and enVista MX60E monofocal intraocular lenses (IOLs)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
9 sitesCanada
Study dates
10 Mar 2020to 14 Jun 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be 18 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 Best-corrected Distance Visual Acuity (CDVA) equal to or worse than 20/40 in at least one 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 Best-corrected Distance Visual Acuity (CDVA) projected to be equal to or 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.
  • Subjects must have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination and must be willing to refrain from use of contact lenses throughout the clinical study.
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  • 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 +27.0 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 participated in an investigational 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.
  • 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.
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  • Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
  • Subjects with instability of keratometry or biometry measurements.
  • 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.
  • Subjects who have current or previous usage of an alpha-I-selective adrenoceptor blocking agent or an antagonist of alpha IA adrenoceptor (e.g., Flomax® (tamsulosin HCI), Terazosin, or Cardura).
  • 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/ I 00 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 as measured by corneal topography, 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.
  • 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 nursing, lactating, 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 with abnormal pupillary dilation dynamics (as determined by the medical judgment of the investigator) or eccentric or ectopic pupils in either eye.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • Bausch Site 101

    Boisbriand, Quebec, J7H 0E8

  • Bausch Site 106

    Calgary, Alberta

  • Bausch Site 102

    Concord, Ontario, L4K 2Z5

  • Bausch Site 113

    Longueuil, Quebec

  • Bausch Site 103

    Mississauga, Ontario, L6H 0J8

  • Bausch Site 104

    Montreal, Quebec

  • Bausch Site 105

    Toronto, Ontario

  • Bausch Site 107

    Toronto, Ontario

  • Bausch Site 108

    Vaughan, Ontario

Other trials in Canada

About this study

Official title: A Prospective, Multicenter, Randomized, Masked, Controlled Clinical Study to Evaluate the Safety and Performance 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 performance of the enVista trifocal intraocular lens when implanted in the capsular bag.

Conditions
Cataract
Being tested
enVista MX60EFH trifocal intraocular lenses (IOLs), enVista MX60E monofocal intraocular lenses (IOLs)
Medical subject headings
Cataract

What participants receive

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

  • enVista MX60EFH trifocal intraocular lenses (IOLs)Device

    enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally

  • enVista MX60E monofocal intraocular lenses (IOLs)Device

    enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally

Study groups in NCT04224155
Study groupRoleWhat they receive
enVista MX60EFH trifocal intraocular lens (IOL)ExperimentalNot described
Receives: Device: enVista MX60EFH trifocal intraocular lenses (IOLs)
enVista MX60E monofocal intraocular lens (IOL)Active comparatorNot described
Receives: Device: enVista MX60E monofocal intraocular lenses (IOLs)

What is being measured

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

  1. Serious Adverse Events

    All serious adverse events through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye IOL implantation

  2. Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens

    The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). The rate was determined as the number of eyes with an SSI related to the optical properties of the IOL divided by the total number of eyes.

    Measured: Day 120 to Day 180 after second eye IOL implantation

  3. Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes

    Photopic uncorrected distance visual acuity (UDVA) for first implanted eyes at 4 m at Post.Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye IOL implantation

  4. Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively

    Photopic uncorrected near and intermediate visual acuity (UNVA and UIVA) for first implanted eyes at 40 cm and 66 cm, respectively, at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye IOL implantation

  5. The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.

    The incidence of adverse events (AEs), through Postoperative Visit 4 (Day 120 to Day 180 after second eye IOL implantation), compared to ISO Safety and Performance Endpoint rates as defined in ISO 11979-7:2018 and EN ISO 11979-7:2018 Annex E. The observed AE rate was calculated as 100 multiplied by the number of eyes with the specific treatment-emergent event divided by the number of implanted eyes.

    Measured: Day 120 to Day 180 after second eye IOL implantation

Secondary outcomes (6)

  1. Incidence of Subjects Experiencing at Least One Severe Visual Disturbance

    The incidence of Patient-Reported Outcomes Set subjects experiencing at least one severe visual disturbance, defined as the highest grade of severity or bothersomeness (separately) reported by subjects using the Quality of Vision (QoV) questionnaire at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Incidence was calculated as 100 multiplied by Count of Participants experiencing at least one severe visual disturbance divided by Number of Participants Analyzed.

    Measured: Day 120 to Day 180 after second eye IOL implantation

  2. Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4

    Photopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation).

    Binocular photopic (approximately 85 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd) and was assessed in log units.

    Measured: Day 120 to Day 180 after second eye IOL implantation

  3. Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4

    Mesopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.

    Measured: Day 120 to Day 180 after second eye IOL implantation

  4. Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4

    Mesopic contrast sensitivity without glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity without glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.

    Measured: Day 120 to Day 180 after second eye IOL implantation

  5. IOL Rotation for All Eyes at Post-Operative Visit 4

    IOL rotation for all eyes at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye IOL implantation

  6. Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4

    Change from baseline ( preoperative ) in uncorrected photopic near and intermediate visual acuity (UNVA and UIVA) at 40 cm and 66 cm, respectively, for first implanted eyes to Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)

    Measured: Day 120 to Day 180 after second eye IOL implantation

Timeline

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

  1. First posted13 Jan 2020
  2. Study start10 Mar 2020
  3. Primary completion14 Jun 2022
  4. Study completion14 Jun 2022

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04224155
Sponsor's protocol ID
900
Status last verified
Feb 2024
First submitted
8 Jan 2020
Last updated
10 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Muzychuk A, Harasymowycz P. Efficacy and safety evaluation of a new full visual range vs monofocal intraocular lens in patients with cataract: randomized, controlled Canadian clinical trial. J Cataract Refract Surg. 2025 Oct 1;51(10):867-875. doi: 10.1097/j.jcrs.0000000000001714.

    PubMed 40490939

Questions about this trial

What is this clinical trial studying?

A study testing enVista MX60EFH trifocal intraocular lenses (IOLs) and enVista MX60E monofocal intraocular lenses (IOLs) in people with Cataract, run by Bausch & Lomb Incorporated at 9 sites in Canada.

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 9 inclusion and 20 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. 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 18 Apr 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?

Serious Adverse Events (time frame: Day 120 to Day 180 after second eye IOL implantation). The study lists 5 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 NCT04224155, which also lists 1 linked publication.

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 10 Oct 2024.

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