Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)
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|ClinicalTrials.gov Identifier: NCT00747565|
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : December 2, 2010
Last Update Posted : March 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Tecnis ZM900 Multifocal Intraocular Lens Device: CeeOn 911A monofocal IOL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Tecnis Multifocal IOL group
Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
Device: Tecnis ZM900 Multifocal Intraocular Lens
Investigational intraocular lens
Active Comparator: CeeOn 911A monofocal control IOL group
Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
Device: CeeOn 911A monofocal IOL
Monofocal Control IOL
- Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. [ Time Frame: One year ]Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
- Mean Binocular Distance Corrected Near Visual Acuity in Snellen [ Time Frame: One year ]Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747565
|Principal Investigator:||Mark Packer, M.D.||Drs. Fine, Hoffman and Packer|