Trials / Completed
CompletedNCT03603600
Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens
A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 501 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | enVista MX60E | enVista MX60E monofocal IOL |
| DEVICE | enVista MX60EF | enVista MX60EF (trifocal) multifocal IOL (MIOL) |
Timeline
- Start date
- 2018-05-31
- Primary completion
- 2023-05-04
- Completion
- 2023-05-04
- First posted
- 2018-07-27
- Last updated
- 2024-12-24
- Results posted
- 2024-12-24
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03603600. Inclusion in this directory is not an endorsement.