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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758745
• Other study ID #: P-06-03
• Status: Completed
• Phase: N/A
• First received: September 23, 2008
• Last updated: August 15, 2014
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Model SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
• Model MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Study Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No