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

NCT ID: NCT06333015

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2026-07-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

enVista Beyond EY IOL

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

Group Type: EXPERIMENTAL

enVista Beyond EY (EDF) IOL

Intervention Type: DEVICE

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

enVista MX60E monofocal IOL

Subjects implanted with enVista MX60E monofocal IOL

Group Type: ACTIVE_COMPARATOR

enVista MX60E monofocal IOL

Intervention Type: DEVICE

enVista MX60E monofocal IOL

Interventions

enVista Beyond EY (EDF) IOL

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

Intervention Type: DEVICE

enVista MX60E monofocal IOL

enVista MX60E monofocal IOL

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosangela Sonner

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Site 119

Dothan, Alabama, United States

Site 108

Northridge, California, United States

Site 116

Alexandria, Minnesota, United States

Site 107

Bloomington, Minnesota, United States

Site 101

Omaha, Nebraska, United States

Site 109

Las Vegas, Nevada, United States

Site 113

Garden City, New York, United States

Site 118

West Fargo, North Dakota, United States

Site 102

Brecksville, Ohio, United States

Site 105

North Charleston, South Carolina, United States

Site 106

Sioux Falls, South Dakota, United States

Site 103

Dallas, Texas, United States

Site 117

San Antonio, Texas, United States

Site 112

San Antonio, Texas, United States

Site 115

Sugar Land, Texas, United States

Site 111

Mount Pleasant, Wisconsin, United States

Countries

United States

Other Identifiers

924

Identifier Type: -

Identifier Source: org_study_id