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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03603600
Collaborator
(none)
501
Enrollment
21
Locations
2
Arms
50.1
Anticipated Duration (Months)
23.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: enVista MX60E
  • Device: enVista MX60EF
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
501 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 IOLApproximately 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
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 28, 2018
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: enVista MX60EF

enVista MX60EF (trifocal) multifocal IOL (MIOL)

Device: enVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)

Sham Comparator: enVista MX60E

enVista MX60E monofocal IOL

Device: enVista MX60E
enVista MX60E monofocal IOL

Outcome Measures

Primary Outcome Measures

  1. Photopic monocular best-corrected distance visual acuity (BCDVA) [Day 120 to Day 180]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Exclusion Criteria:
  1. Subjects who have participated in any drug or device clinical investigation 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Bausch Site 108FayettevilleArkansasUnited States72703
2Bausch Site 113Garden GroveCaliforniaUnited States02843
3Bausch Site 120NorthridgeCaliforniaUnited States91325
4Bausch Site 115ReddingCaliforniaUnited States96002
5Bausch Site 103TorranceCaliforniaUnited States90505
6Bausch Site 107Mount DoraFloridaUnited States32757
7Bausch Site 117Lake VillaIllinoisUnited States60046
8Bausch Site 101BloomingtonMinnesotaUnited States55420
9Bausch Site 119BirminghamMississippiUnited States49009
10Bausch Site 102Saint LouisMissouriUnited States63131
11Bausch Site 118Las VegasNevadaUnited States89145
12Bausch Site 106BrecksvilleOhioUnited States44141
13Bausch Site 109ColumbusOhioUnited States43215
14Bausch Site 116PittsburghPennsylvaniaUnited States16066
15Bausch Site 121Sioux FallsSouth DakotaUnited States57108
16Bausch Site 112MemphisTennesseeUnited States38119
17Bausch Site 110NashvilleTennesseeUnited States37205
18Bausch Site 104Cedar ParkTexasUnited States78613
19Bausch Site 105DallasTexasUnited States75243
20Bausch Site 111HoustonTexasUnited States77008
21Bausch Site 122San AntonioTexasUnited States78215

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Anya Loncaric, Bausch health companies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03603600
Other Study ID Numbers:
  • 945
First Posted:
Jul 27, 2018
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021