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CataractNCT06333015

Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

A study testing enVista Beyond EY (EDF) IOL and enVista MX60E monofocal IOL in people with Cataract, run by Bausch & Lomb Incorporated at 16 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

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cataract
What is being tested?
enVista Beyond EY (EDF) IOL and enVista MX60E monofocal IOL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
16 sitesUnited States
Study dates
7 Aug 2024to 11 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • 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) approved 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 present (Brightness Acuity Tester), or have significant cataract-related visual symptoms, 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 preoperative corneal astigmatism less than 1.0 D for each eye.
  • Subjects must have a BCDVA projected to be better than 20/30 after cataract removal and 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.
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  • Contact lens wearers must demonstrate a stable refraction (within ±0.50 D in magnitude for both sphere and cylinder and within ±15° in axis) in both eyes, as determined by distance manifest refraction on two consecutive examination dates (both refractions performed at least 7 days apart) after discontinuation of contact lens wear (Rigid or Toric lenses discontinued for at least 2 weeks and soft contact lenses discontinued for at least 3 days prior to the first refraction used to establish stability and through the day of surgery).
  • Subjects must require an IOL power from +14.0 diopter (D) to +28.0 D for each eye.
  • 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 the planned first surgery date and/or will participate in another investigation during the period of study participation.
  • Subjects with presence of any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.), not including mild superficial punctate keratitis (SPK) (confirmed by corneal staining), in either eye.
  • Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens.
  • Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than 3 topical drugs for IOP control).
  • Subjects with previous retinal detachment or presence or history of clinically significant retinal pathology involving the macula in either eye.
  • Subjects with presence of 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 using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of randomization (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 with presence or history of diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are expected to cause future visual acuity losses to a level of 20/30 or worse in either eye.
  • Subjects who have had previous intraocular or corneal surgery in either eye that might confound the outcome of the investigation or increase the risk to the subject.
  • Subjects with any active infectious conjunctivitis, keratitis, or uveitis in either eye.
  • Subjects who have irregular astigmatism or skewed radial axis for either eye.
  • Subjects who cannot achieve a minimum pharmacologic pupil dilation of at least 5.0 mm in both eyes.
  • Subjects who may be expected to require a combined or other secondary surgical procedure in either eye (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
  • Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from the study if they are currently pregnant or plan to become pregnant during the study, lactating or have a condition associated with fluctuation hormones that could lead to refractive changes. Females of childbearing potential must be willing to practice effective contraception for the duration of their participation in the study.
  • Subjects with any other serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety, increases the operative risk or could confound the results of the study.
  • Subjects who have current or previous usage of systemic medications that may confound the outcome or increase the risk to the subject based on the Investigator's judgement. For example; subjects on an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., tamsulosin hydrochloride (Flomax®), Terazosin, Rapaflo or Cardura) or other medications with similar side effects (floppy iris syndrome).
  • Subjects who are expected to require retinal laser treatment.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Site 116

    Alexandria, Minnesota, 56308

  • Site 107

    Bloomington, Minnesota, 55420

  • Site 102

    Brecksville, Ohio, 44141

  • Site 103

    Dallas, Texas, 75243

  • Site 119

    Dothan, Alabama, 36301

  • Site 113

    Garden City, New York, 11530

  • Site 109

    Las Vegas, Nevada, 89145

  • Site 111

    Mount Pleasant, Wisconsin, 53405

  • Site 105

    North Charleston, South Carolina, 29406

  • Site 108

    Northridge, California, 91325

  • Site 101

    Omaha, Nebraska, 68137

  • Site 117

    San Antonio, Texas, 78209

  • Site 112

    San Antonio, Texas, 78229

  • Site 106

    Sioux Falls, South Dakota, 57108

  • Site 115

    Sugar Land, Texas, 77478

  • Site 118

    West Fargo, North Dakota, 58078

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes.

Read the detailed description

The study will evaluate the safety and effectiveness of the enVista Beyond (EY) EDF IOL in providing increased depth of focus, comparable distance and improved near and intermediate visual acuity compared to the parent enVista monofocal IOL. This is a prospective, multicenter, randomized, controlled, subject and visual acuity assessor masked, parallel-group study in subjects bilaterally implanted with either EY or enVista MX60E monofocal IOL following cataract surgery.

Conditions
Cataract
Being tested
enVista Beyond EY (EDF) IOL, enVista MX60E monofocal IOL
Medical subject headings
Cataract

What participants receive

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

  • enVista Beyond EY (EDF) IOLDevice

    enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY

  • enVista MX60E monofocal IOLDevice

    enVista MX60E monofocal IOL

Study groups in NCT06333015
Study groupRoleWhat they receive
enVista Beyond EY IOLExperimentalSubjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
Receives: Device: enVista Beyond EY (EDF) IOL
enVista MX60E monofocal IOLActive comparatorSubjects implanted with enVista MX60E monofocal IOL
Receives: Device: enVista MX60E monofocal IOL

What is being measured

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

  1. Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.

    Monocular photopic DCIVA (logMAR) will be measured at 66 cm in the first implanted eye.

    Measured: Day 120 to Day 180 after second eye implantation

  2. Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.

    Monocular photopic DCIVA (logMAR) will be measured at 66 cm in the first implanted eye.

    Measured: Day 120 to Day 180 after second eye implantation

  3. Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.

    Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR in the first implanted eye.

    Measured: Day 120 to Day 180 after second eye implantation

  4. Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.

    Monocular Photopic Best-Corrected Distance Visual Acuity (BCDVA) (logMAR) will be measured at 4 meters in the first implanted eye.

    Measured: Day 120 to Day 180 after second eye implantation

  5. Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.

    Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better in the first implanted eye. Monocular Photopic Best-Corrected Distance Visual Acuity (BCDVA) (logMAR) will be measured at 4 meters.

    Measured: Day 120 to Day 180 after second eye implantation

Secondary outcomes (1)

  1. Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4.

    Monocular photopic DCNVA (logMAR) will be measured at 40 cm in the first implanted eye.

    Measured: Day 120 to Day 180 after second eye implantation

Timeline

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

  1. First posted27 Mar 2024
  2. Study start7 Aug 2024
  3. Primary completion11 Jun 2026
  4. Study completion11 Jun 2026

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 299 subjects will be randomized in the study. In the first phase 224 subjects will be randomized at a 1:1 ratio to either the test or control IOL, and in the second phase 75 subjects will be randomized at a 2:1 ratio to either the test or control IOL.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333015
Sponsor's protocol ID
924
Status last verified
Jul 2026
First submitted
20 Mar 2024
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing enVista Beyond EY (EDF) IOL and enVista MX60E monofocal IOL in people with Cataract, run by Bausch & Lomb Incorporated at 16 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 9 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. (time frame: Day 120 to Day 180 after second eye 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 NCT06333015.

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 13 Jul 2026.

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