Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens

NCT03603600 | Completed Results FDA Device

• 1 other identifier: 945
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 23

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (6)

• Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)

  Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)

  Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)

  Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Serious Adverse Events

  All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit

  Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

• The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit

  The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.

  Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

• The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint

  The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes

  Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

Secondary Outcomes (7)

• Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Photopic Binocular UNVA at 40 cm at Postoperative Visit 4

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• Photopic Binocular UIVA at 66 cm at Postoperative Visit 4

  Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

• First-eye BCDVA Evaluated at Postoperative Visit 5

  Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

Study Arms (2)

enVista MX60EF

EXPERIMENTAL

enVista MX60EF (trifocal) multifocal IOL (MIOL)

Device: enVista MX60EF

enVista MX60E

ACTIVE COMPARATOR

enVista MX60E monofocal IOL

Device: enVista MX60E

Interventions

enVista MX60E DEVICE

enVista MX60E monofocal IOL

enVista MX60E

enVista MX60EF DEVICE

enVista MX60EF (trifocal) multifocal IOL (MIOL)

enVista MX60EF

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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)/Independent Ethics Committee (IEC) approved Informed Consent Form (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, 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 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.
• 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 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.
• Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
• 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 entry into this study and/or will participate in another investigation during the period of study participation.
• Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye.
• 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.
• Subjects who have uncontrolled glaucoma in either eye.
• Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
• Subjects who have 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 enrollment or during the study (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 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.
• Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
• Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
• 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).
• Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
• Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (23)

Bausch Site 108

Fayetteville, Arkansas, 72703, United States

Location

Bausch Site 113

Garden Grove, California, 02843, United States

Location

Bausch Site 120

Northridge, California, 91325, United States

Location

Bausch Site 115

Redding, California, 96002, United States

Location

Bausch Site 103

Torrance, California, 90505, United States

Location

Bausch Site 107

Mt. Dora, Florida, 32757, United States

Location

Bausch Site 117

Lake Villa, Illinois, 60046, United States

Location

Bausch Site 101

Bloomington, Minnesota, 55420, United States

Location

Bausch Site 119

Birmingham, Mississippi, 49009, United States

Location

Bausch Site 102

St Louis, Missouri, 63131, United States

Location

Bausch Site 124

Omaha, Nebraska, 68137, United States

Location

Bausch Site 118

Las Vegas, Nevada, 89145, United States

Location

Bausch Site 106

Brecksville, Ohio, 44141, United States

Location

Bausch Site 109

Columbus, Ohio, 43215, United States

Location

Bausch Site 116

Pittsburgh, Pennsylvania, 16066, United States

Location

Bausch Site 121

Sioux Falls, South Dakota, 57108, United States

Location

Bausch Site 112

Memphis, Tennessee, 38119, United States

Location

Bausch Site 110

Nashville, Tennessee, 37205, United States

Location

Bausch Site 104

Cedar Park, Texas, 78613, United States

Location

Bausch Site 105

Dallas, Texas, 75243, United States

Location

Bausch Site 111

Houston, Texas, 77008, United States

Location

Bausch Site 122

San Antonio, Texas, 78215, United States

Location

Bausch Site 123

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Johnson Varughese
• Organization: Bausch & Lomb

Johnson.Varughese@bausch.com

9089271162

Study Officials

• Rosangela Nolasco

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: May 31, 2018
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Locations

US (23)