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

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

Conditions
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Cataract

Intervention / Treatment
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* Device: SN60AT
* Device: SN60WF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SN60AT<br>Implantation with the AcrySof Intraocular Lens Model SN60AT | Device: SN60AT<br>* Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.<br>|
| Active Comparator: SN60WF<br>Implantation with the AcrySof Intraocular Lens Model SN60WF | Device: SN60WF<br>* Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract