Trials / Completed
CompletedNCT01852084
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
To Evaluate the Safety and Effectiveness of the EnVista® One-Piece Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism on Postoperative Refraction Following Cataract Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 191 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.
Detailed description
The investigational enVista Toric IOL, Model MX60T, and the currently approved Model MX60, are identical with the exception of the addition of toric optics and axis marks on the posterior optic surface for the correction of astigmatism on the Model MX60T. Both lenses have an aspheric biconvex optic with a modified C haptic monoblock, single-piece design. The design and material of both the MX60 and MX60T allow them to be folded and inserted through small incisions to minimize the possibility of surgically induced astigmatism (SIA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | enVista® One-Piece Hydrophobic Acrylic Toric IOL | Test lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D |
| DEVICE | enVista control lens | Spherical Control lens |
Timeline
- Start date
- 2013-03-06
- Primary completion
- 2016-07-18
- Completion
- 2016-12-01
- First posted
- 2013-05-13
- Last updated
- 2020-09-16
- Results posted
- 2020-09-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01852084. Inclusion in this directory is not an endorsement.