Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
|ClinicalTrials.gov Identifier: NCT00758745|
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : July 28, 2011
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Model SN60WF Device: Model MA60AC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: Model SN60WF
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
Device: Model SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
Active Comparator: Model MA60AC
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Device: Model MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
- Posterior Capsule Opacification (PCO) [ Time Frame: Up to 3 years ]Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758745
|United States, Texas|
|Contact Alcon Call Center for Study Locations|
|Fort Worth, Texas, United States, 76134|