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

NCT06333015 | Active Not Recruiting FDA Device

• 1 other identifier: 924
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 16

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

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

  Day 120 to Day 180 after second eye implantation

Study Arms (2)

enVista Beyond EY IOL

EXPERIMENTAL

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

Device: enVista Beyond EY (EDF) IOL

enVista MX60E monofocal IOL

ACTIVE COMPARATOR

Subjects implanted with enVista MX60E monofocal IOL

Device: enVista MX60E monofocal IOL

Interventions

enVista Beyond EY (EDF) IOL DEVICE

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

enVista Beyond EY IOL

enVista MX60E monofocal IOL DEVICE

enVista MX60E monofocal IOL

enVista MX60E monofocal IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (16)

Site 119

Dothan, Alabama, 36301, United States

Location

Site 108

Northridge, California, 91325, United States

Location

Site 116

Alexandria, Minnesota, 56308, United States

Location

Site 107

Bloomington, Minnesota, 55420, United States

Location

Site 101

Omaha, Nebraska, 68137, United States

Location

Site 109

Las Vegas, Nevada, 89145, United States

Location

Site 113

Garden City, New York, 11530, United States

Location

Site 118

West Fargo, North Dakota, 58078, United States

Location

Site 102

Brecksville, Ohio, 44141, United States

Location

Site 105

North Charleston, South Carolina, 29406, United States

Location

Site 106

Sioux Falls, South Dakota, 57108, United States

Location

Site 103

Dallas, Texas, 75243, United States

Location

Site 117

San Antonio, Texas, 78209, United States

Location

Site 112

San Antonio, Texas, 78229, United States

Location

Site 115

Sugar Land, Texas, 77478, United States

Location

Site 111

Mount Pleasant, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Rosangela Sonner

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)