Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
1 other identifier
interventional
81
1 country
1
Brief Summary
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
July 28, 2011
CompletedAugust 19, 2014
August 1, 2011
3.9 years
September 23, 2008
July 1, 2011
August 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Posterior Capsule Opacification (PCO)
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.
Up to 3 years
Study Arms (2)
Model SN60WF
ACTIVE COMPARATORImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
Model MA60AC
ACTIVE COMPARATORImplantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Interventions
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
Eligibility Criteria
You may qualify if:
- Age \> 50 years
- Clear cornea
- Pupil mydriasis ≥ 7mm
- In the bag Intraocular Lens (IOL)
You may not qualify if:
- Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
- Previously operated eye
- Proliferative diabetic retinopathy
- Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
January 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 19, 2014
Results First Posted
July 28, 2011
Record last verified: 2011-08