Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Model SN60WF; Device: Model MA60AC

• Registration Number: NCT00758745
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-07-01
• Results First Submitted QC: 2011-07-01
• Results First Posted: 2011-07-28
• Status Verified: 2011-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Model SN60WF	Model SN60WF	Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
Model MA60AC	Model MA60AC	Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)

Primary Outcome Measures

Name	Time	Method
Posterior Capsule Opacification (PCO)	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Study Locations; 🇺🇸 Fort Worth, Texas, United States