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

NCT ID: NCT03603600

Last Updated: 2024-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2023-05-04

Brief Summary

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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

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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enVista MX60EF

enVista MX60EF (trifocal) multifocal IOL (MIOL)

Group Type EXPERIMENTAL

enVista MX60EF

Intervention Type DEVICE

enVista MX60EF (trifocal) multifocal IOL (MIOL)

enVista MX60E

enVista MX60E monofocal IOL

Group Type ACTIVE_COMPARATOR

enVista MX60E

Intervention Type DEVICE

enVista MX60E monofocal IOL

Interventions

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enVista MX60E

enVista MX60E monofocal IOL

Intervention Type DEVICE

enVista MX60EF

enVista MX60EF (trifocal) multifocal IOL (MIOL)

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosangela Nolasco

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch Site 108

Fayetteville, Arkansas, United States

Site Status

Bausch Site 113

Garden Grove, California, United States

Site Status

Bausch Site 120

Northridge, California, United States

Site Status

Bausch Site 115

Redding, California, United States

Site Status

Bausch Site 103

Torrance, California, United States

Site Status

Bausch Site 107

Mt. Dora, Florida, United States

Site Status

Bausch Site 117

Lake Villa, Illinois, United States

Site Status

Bausch Site 101

Bloomington, Minnesota, United States

Site Status

Bausch Site 119

Birmingham, Mississippi, United States

Site Status

Bausch Site 102

St Louis, Missouri, United States

Site Status

Bausch Site 124

Omaha, Nebraska, United States

Site Status

Bausch Site 118

Las Vegas, Nevada, United States

Site Status

Bausch Site 106

Brecksville, Ohio, United States

Site Status

Bausch Site 109

Columbus, Ohio, United States

Site Status

Bausch Site 116

Pittsburgh, Pennsylvania, United States

Site Status

Bausch Site 121

Sioux Falls, South Dakota, United States

Site Status

Bausch Site 112

Memphis, Tennessee, United States

Site Status

Bausch Site 110

Nashville, Tennessee, United States

Site Status

Bausch Site 104

Cedar Park, Texas, United States

Site Status

Bausch Site 105

Dallas, Texas, United States

Site Status

Bausch Site 111

Houston, Texas, United States

Site Status

Bausch Site 122

San Antonio, Texas, United States

Site Status

Bausch Site 123

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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945

Identifier Type: -

Identifier Source: org_study_id