Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
NCT01191229 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2012-06-14
Summary
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.
Conditions
- To Collect Information About Visual Outcomes and Participant Satisfaction
Interventions
- DEVICE
-
Tecnis one-piece MF IOL
25 patients to be implanted after cataract surgery
- DEVICE
-
Crystalens AO
25 patients that are previously implanted
Sponsors & Collaborators
-
Innovative Medical
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- United States
Study Locations
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