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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: enVista MX60E monofocal IOL; Device: enVista Beyond EY (EDF) IOL

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Site 119
  • California
    • Northridge, California, United States, 91325
      • Site 108
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Site 116
    • Bloomington, Minnesota, United States, 55420
      • Site 107
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Site 101
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Site 109
  • New York
    • Garden City, New York, United States, 11530
      • Site 113
  • North Dakota
    • West Fargo, North Dakota, United States, 58078
      • Site 118
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Site 102
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Site 105
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Site 106
  • Texas
    • Dallas, Texas, United States, 75243
      • Site 103
    • San Antonio, Texas, United States, 78229
      • Site 112
    • San Antonio, Texas, United States, 78209
      • Site 117
    • Sugar Land, Texas, United States, 77478
      • Site 115
  • Wisconsin
    • Mount Pleasant, Wisconsin, United States, 53405
      • Site 111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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) approved 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 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.
4. Subjects must have preoperative corneal astigmatism less than 1.0 D for each eye.
5. 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.
6. Subjects must have clear intraocular media other than the cataract in both eyes.
7. 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).
8. Subjects must require an IOL power from +14.0 diopter (D) to +28.0 D for each eye.
9. 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 the planned first surgery date and/or will participate in another investigation during the period of study participation.
2. 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.
3. 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.
4. 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).
5. Subjects with previous retinal detachment or presence or history of clinically significant retinal pathology involving the macula in either eye.
6. Subjects with presence of 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 randomization (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 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.
11. 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.
12. Subjects with any active infectious conjunctivitis, keratitis, or uveitis in either eye.
13. Subjects who have irregular astigmatism or skewed radial axis for either eye.
14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of at least 5.0 mm in both eyes.
15. 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).
16. 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.
17. 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.
18. 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).
19. Subjects who are expected to require retinal laser treatment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enVista Beyond EY IOL; Subjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY	Device: enVista Beyond EY (EDF) IOL; enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
Active Comparator: enVista MX60E monofocal IOL; Subjects implanted with enVista MX60E monofocal IOL	Device: enVista MX60E monofocal IOL; enVista MX60E monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 120 to Day 180 after second eye implantation
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.	Day 120 to Day 180 after second eye implantation
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.	Day 120 to Day 180 after second eye implantation
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.	Day 120 to Day 180 after second eye implantation
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.	Day 120 to Day 180 after second eye implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 120 to Day 180 after second eye implantation

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Rosangela Sonner, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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