Clinical trial NCT06333015: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 224
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs.
Primary purpose: TREATMENT

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.

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)/Research Ethics Board (REB) 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 + 16.0 diopter (D) to + 24.0 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 who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) 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)\>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 clinically significant retinal pathology involving the macula in either eye.
6. Subjects who have 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 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 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 enrollment in 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 hyrdrochloride (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

Primary outcomes:
measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
Secondary outcomes:
measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4.
timeFrame: Day 120 to Day 180 after second eye implantation
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Site 108
state: California
city: Bloomington
country: United States
facility: Site 107
state: Minnesota
city: Omaha
country: United States
facility: Site 101
state: Nebraska
city: Las Vegas
country: United States
facility: Site 109
state: Nevada
city: Garden City
country: United States
facility: Site 113
state: New York
city: Brecksville
country: United States
facility: Site 102
state: Ohio
city: North Charleston
country: United States
facility: Site 105
state: South Carolina
city: Sioux Falls
country: United States
facility: Site 106
state: South Dakota
city: Dallas
country: United States
facility: Site 103
state: Texas
city: San Antonio
country: United States
facility: Site 112
state: Texas
city: Mount Pleasant
country: United States
facility: Site 111
state: Wisconsin
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rosangela Sonner
role: STUDY_DIRECTOR
References: