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

N/ACompletedNCT00762021

Alcon Research104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Cataract

Interventions

SN60ATDEVICE

Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.

SN60WFDEVICE

Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years after surgery

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.

Time frame: 24 months after surgery

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.

Time frame: 24 months after surgery

Data from ClinicalTrials.gov

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