Trials / Completed
CompletedNCT01714635
Clinical Investigation of Expanded Designs of a Multifocal IOL
Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 445 (actual)
- Sponsor
- Abbott Medical Optics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tecnis Multifocal Intraocular Lens | |
| DEVICE | Monofocal Intraocular Lens |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-10-01
- Completion
- 2014-07-01
- First posted
- 2012-10-26
- Last updated
- 2015-03-17
- Results posted
- 2015-01-15
Locations
18 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01714635. Inclusion in this directory is not an endorsement.