Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: SN60AT; Device: SN60WF

• Registration Number: NCT00762021
• Lead Sponsor: Alcon Research

Brief Summary

To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-08
• Results First Submitted: 2010-09-30
• Status Verified: 2010-11
• Results First Submitted QC: 2010-11-24
• Last Update Submitted: 2010-11-24
• Results First Posted: 2010-12-22
• Last Update Posted: 2010-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• patients with bilateral senile cataracts
• Age > 50 years
• Fit for hospital follow ups
• Pupils dilating > 6mm preoperatively
• Eyes expected to see 6/12 or better postoperatively

Exclusion Criteria

• Diabetes
• On treatment for glaucoma
• Other ocular pathology
• Previous ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SN60AT	SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60AT
SN60WF	SN60WF	Implantation with the AcrySof Intraocular Lens Model SN60WF

Primary Outcome Measures

Name	Time	Method
Posterior Capsule Opacification (PCO)	2 years after surgery	Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
100% LogMAR Best Corrected Visual Acuity (BCVA)	24 months after surgery	Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.; VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
9% LogMAR Best Corrected Visual Acuity (BCVA)	24 months after surgery	Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.; VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Trial Locations

Locations (1)

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