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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762021
• Other study ID #: P-06-26
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: November 24, 2010
• Start date: December 2006

Study information

• Verified date: November 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
• SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial 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)	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.	2 years after surgery	No
Primary	100% LogMAR Best Corrected Visual Acuity (BCVA)	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.	24 months after surgery	No
Primary	9% LogMAR Best Corrected Visual Acuity (BCVA)	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.	24 months after surgery	No