Clinical trial NCT03603600: Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
Official title: A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 501
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 334 subjects will be implanted bilaterally with the enVista MX60EF trifocal MIOL, and approximately 167 control subjects will be implanted bilaterally with the enVista MX60E monofocal IOL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

Detailed description: Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

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)/Independent Ethics Committee (IEC) approved Informed Consent Form (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, 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 a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.
5. Subjects must have clear intraocular media other than the cataract in both eyes.
6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear.
7. Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
8. 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 entry into this study 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 who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
4. Subjects who have uncontrolled glaucoma in either eye.
5. Subjects who have 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 enrollment or during the study (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 who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/100 or worse in either eye.
11. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
13. Subjects who have a preoperative corneal astigmatism \> 1.0 D in either eye, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
16. Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Investigator.
17. 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. Females of childbearing potential must be willing to practice effective contraception for the duration of the study.
18. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study.
19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura).

Primary outcomes:
measure: Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Serious Adverse Events
timeFrame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
measure: The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
timeFrame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
measure: The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
timeFrame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Secondary outcomes:
measure: Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
timeFrame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
measure: First-eye BCDVA Evaluated at Postoperative Visit 5
timeFrame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
measure: First-eye DCNVA Evaluated at Postoperative Visit 5
timeFrame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
measure: First-eye DCIVA Evaluated at Postoperative Visit 5
timeFrame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Bausch Site 108
state: Arkansas
city: Garden Grove
country: United States
facility: Bausch Site 113
state: California
city: Northridge
country: United States
facility: Bausch Site 120
state: California
city: Redding
country: United States
facility: Bausch Site 115
state: California
city: Torrance
country: United States
facility: Bausch Site 103
state: California
city: Mount Dora
country: United States
facility: Bausch Site 107
state: Florida
city: Lake Villa
country: United States
facility: Bausch Site 117
state: Illinois
city: Bloomington
country: United States
facility: Bausch Site 101
state: Minnesota
city: Birmingham
country: United States
facility: Bausch Site 119
state: Mississippi
city: Saint Louis
country: United States
facility: Bausch Site 102
state: Missouri
city: Omaha
country: United States
facility: Bausch Site 124
state: Nebraska
city: Las Vegas
country: United States
facility: Bausch Site 118
state: Nevada
city: Brecksville
country: United States
facility: Bausch Site 106
state: Ohio
city: Columbus
country: United States
facility: Bausch Site 109
state: Ohio
city: Pittsburgh
country: United States
facility: Bausch Site 116
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Bausch Site 121
state: South Dakota
city: Memphis
country: United States
facility: Bausch Site 112
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 110
state: Tennessee
city: Cedar Park
country: United States
facility: Bausch Site 104
state: Texas
city: Dallas
country: United States
facility: Bausch Site 105
state: Texas
city: Houston
country: United States
facility: Bausch Site 111
state: Texas
city: San Antonio
country: United States
facility: Bausch Site 122
state: Texas
city: San Antonio
country: United States
facility: Bausch Site 123
state: Texas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rosangela Nolasco
role: STUDY_DIRECTOR
References: