Trials / Completed
CompletedNCT01292629
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Hoya Surgical Optics, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Detailed description
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iSert 251 intraocular lens | aphakic intraocular lens |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2011-02-09
- Last updated
- 2015-03-20
- Results posted
- 2015-03-20
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01292629. Inclusion in this directory is not an endorsement.