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Intraocular Lens
Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
N/A
Waitlist Available
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 120 to day 180 after second eye implantation
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new type of lens called the enVista trifocal intraocular lens for people over 40 with cataracts. The lens is designed to help them see better at all distances after surgery.
Eligible Conditions
- Cataract
- Pseudoaphakia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 120 to day 180 after second eye implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 120 to day 180 after second eye implantation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Photopic monocular best-corrected distance visual acuity (BCDVA)
Photopic monocular distance-corrected intermediate visual acuity (DCIVA)
Photopic monocular distance-corrected near visual acuity (DCNVA)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: enVista MX60EFExperimental Treatment1 Intervention
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Group II: enVista MX60EActive Control1 Intervention
enVista MX60E monofocal IOL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
enVista MX60EF
2018
N/A
~510
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Who is running the clinical trial?
Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
57,729 Total Patients Enrolled
49 Trials studying Cataract
16,032 Patients Enrolled for Cataract
Anya LoncaricStudy DirectorBausch health companies
39 Previous Clinical Trials
20,162 Total Patients Enrolled
5 Trials studying Cataract
1,751 Patients Enrolled for Cataract