Trials / Completed
CompletedNCT00963742
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 390 (actual)
- Sponsor
- Lenstec Incorporated · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.
Detailed description
The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lenstec Softec HD IOL implantation | surgical removal of cataract and implantation of Softec HD PCIOL |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2009-07-01
- Completion
- 2010-04-01
- First posted
- 2009-08-21
- Last updated
- 2014-03-18
Source: ClinicalTrials.gov record NCT00963742. Inclusion in this directory is not an endorsement.