Status:
COMPLETED
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
Lead Sponsor:
Lenstec Incorporated
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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-op...
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 circul...
Eligibility Criteria
Inclusion
- Cataract requiring cataract extraction
- Study IOL to only be implanted in 1 eye
- Distance BCVA 20/40 or worse or glare acuity worse than 20/30
- Ability to comply with study follow-up requirements
Exclusion
- Patients with serious corneal disease, previous surgery or serious systemic disease
- Ocular condition that could impact vision after cataract surgery
- Pregnant or lactating women
- Use of ocular or systemic medications that could impact vision
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00963742
Start Date
December 1 2006
End Date
April 1 2010
Last Update
March 18 2014
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