Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
NCT ID: NCT00963742
Last Updated: 2014-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
390 participants
INTERVENTIONAL
2006-12-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenstec Softec HD IOL implantation
390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
Lenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Interventions
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Lenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Ocular condition that could impact vision after cataract surgery
* Pregnant or lactating women
* Use of ocular or systemic medications that could impact vision
21 Years
ALL
Yes
Sponsors
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Lenstec Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Donald R Sanders, M.D. Ph.D
Role: STUDY_DIRECTOR
Center for Clinical Research
Other Identifiers
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IDE G060058
Identifier Type: -
Identifier Source: org_study_id
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