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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03603600
Collaborator
(none)
501
Enrollment
23
Locations
2
Arms
59
Anticipated Duration (Months)
21.8
Patients Per Site
0.4
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 Disease Intervention/Treatment Phase
  • 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 31, 2018
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Bausch Site 108 Fayetteville Arkansas United States 72703
2 Bausch Site 113 Garden Grove California United States 02843
3 Bausch Site 120 Northridge California United States 91325
4 Bausch Site 115 Redding California United States 96002
5 Bausch Site 103 Torrance California United States 90505
6 Bausch Site 107 Mount Dora Florida United States 32757
7 Bausch Site 117 Lake Villa Illinois United States 60046
8 Bausch Site 101 Bloomington Minnesota United States 55420
9 Bausch Site 119 Birmingham Mississippi United States 49009
10 Bausch Site 102 Saint Louis Missouri United States 63131
11 Bausch Site 124 Omaha Nebraska United States 68137
12 Bausch Site 118 Las Vegas Nevada United States 89145
13 Bausch Site 106 Brecksville Ohio United States 44141
14 Bausch Site 109 Columbus Ohio United States 43215
15 Bausch Site 116 Pittsburgh Pennsylvania United States 16066
16 Bausch Site 121 Sioux Falls South Dakota United States 57108
17 Bausch Site 112 Memphis Tennessee United States 38119
18 Bausch Site 110 Nashville Tennessee United States 37205
19 Bausch Site 104 Cedar Park Texas United States 78613
20 Bausch Site 105 Dallas Texas United States 75243
21 Bausch Site 111 Houston Texas United States 77008
22 Bausch Site 122 San Antonio Texas United States 78215
23 Bausch Site 123 San Antonio Texas United States 78229

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:
Jun 30, 2022
Last Verified:
Jun 1, 2022
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:
Cataract

Study Results

No Results Posted as of Jun 30, 2022