Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
NCT03603600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2024-12-24
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.
Conditions
- Cataract
Interventions
- DEVICE
-
enVista MX60E
enVista MX60E monofocal IOL
- DEVICE
-
enVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Sponsors & Collaborators
-
Bausch & Lomb Incorporated
lead INDUSTRY
Principal Investigators
-
Rosangela Nolasco · Bausch & Lomb Incorporated
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2023-05-04
- Completion
- 2023-05-04
- FDA Device
- Yes
Countries
- United States
Study Locations
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