Trials / Completed
CompletedNCT04224155
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
A Prospective, Multicenter, Randomized, Masked, Controlled Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | enVista MX60EFH trifocal intraocular lenses (IOLs) | enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally |
| DEVICE | enVista MX60E monofocal intraocular lenses (IOLs) | enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
Timeline
- Start date
- 2020-03-10
- Primary completion
- 2022-06-14
- Completion
- 2022-06-14
- First posted
- 2020-01-13
- Last updated
- 2024-10-10
- Results posted
- 2024-04-18
Locations
9 sites across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04224155. Inclusion in this directory is not an endorsement.