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Intraocular Lens
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
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 iol implantation
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new type of eye lens called the enVista trifocal intraocular lens. It is designed to help people see clearly at different distances after being implanted in the eye. The study focuses on patients who need a lens replacement, often due to cataracts.
Eligible Conditions
- Pseudoaphakia
- Cataract
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 120 to day 180 after second eye iol implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 120 to day 180 after second eye iol implantation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens
Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes
Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively
+2 moreSecondary study objectives
Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4
IOL Rotation for All Eyes at Post-Operative Visit 4
Incidence of Subjects Experiencing at Least One Severe Visual Disturbance
+3 moreAwards & 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 MX60EFH trifocal intraocular lens (IOL)Experimental Treatment1 Intervention
Group II: enVista MX60E monofocal intraocular lens (IOL)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
enVista MX60EFH trifocal intraocular lenses (IOLs)
2020
N/A
~170
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Who is running the clinical trial?
Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
58,065 Total Patients Enrolled
Anya LoncaricStudy DirectorBausch & Lomb Incorporated
39 Previous Clinical Trials
20,498 Total Patients Enrolled