Back to resultsRandomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Model SN60WF
Model MA60AC
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
Eligibility Criteria
Inclusion Criteria:
- Age > 50 years
- Clear cornea
- Pupil mydriasis ≥ 7mm
- In the bag Intraocular Lens (IOL)
Exclusion Criteria:
- 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
Sites / Locations
- Contact Alcon Call Center for Study Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Model SN60WF
Model MA60AC
Arm Description
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758745
Brief Title
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Model SN60WF
Arm Type
Active Comparator
Arm Description
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
Arm Title
Model MA60AC
Arm Type
Active Comparator
Arm Description
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
Model SN60WF
Intervention Description
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
Intervention Type
Device
Intervention Name(s)
Model MA60AC
Intervention Description
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
Primary Outcome Measure Information:
Title
Posterior Capsule Opacification (PCO)
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 50 years
Clear cornea
Pupil mydriasis ≥ 7mm
In the bag Intraocular Lens (IOL)
Exclusion Criteria:
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
Facility Information:
Facility Name
Contact Alcon Call Center for Study Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
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