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Intraocular Lens

enVista EY Beyond Lens for Cataracts

N/A
Recruiting
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

Summary

This trial is testing a new type of lens called the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens in people who will have it put

Who is the study for?
This trial is for individuals planning to undergo cataract extraction and who wish to receive a new type of lens implant called the enVista Beyond IOL. Specific eligibility criteria are not provided, but typically participants should be in good general health with no other eye diseases.
What is being tested?
The study compares two types of intraocular lenses (IOLs): the new enVista Beyond Hydrophobic Acrylic Extended Depth of Focus IOL and the established TECNIS monofocal IOL. Participants will have one of these lenses implanted during cataract surgery.
What are the potential side effects?
While specific side effects are not listed, common risks associated with IOL implants include inflammation, infection, bleeding, swelling, detachment of retina or lens dislocation. Individual experiences may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 120 to day 180 after second eye implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 120 to day 180 after second eye implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.
Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
+2 more
Secondary study objectives
Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: enVista Beyond EY IOLExperimental Treatment1 Intervention
Subjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
Group II: enVista MX60E monofocal IOLActive Control1 Intervention
Subjects implanted with enVista MX60E monofocal IOL

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
255 Previous Clinical Trials
57,416 Total Patients Enrolled
48 Trials studying Cataract
15,859 Patients Enrolled for Cataract
Anya LoncaricStudy DirectorBausch & Lomb Incorporated
39 Previous Clinical Trials
20,439 Total Patients Enrolled
5 Trials studying Cataract
2,028 Patients Enrolled for Cataract
~149 spots leftby Oct 2025
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