A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL; Device: AcrySof Natural IQ (SN60WF) IOL

• Registration Number: NCT01105585
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2011-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
• Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
• <1 diopter corneal astigmatism preoperatively;
• Able to achieve 6.5 mm dilated pupil;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Chronic disease or illness;
• Irregular optical aberration;
• Amblyopia;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
• Diabetic retinopathy;
• Macular degeneration;
• History of retinal detachment;
• Other surgeries planned at time of cataract removal;
• Severe dry eye;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZCB00 IOL	Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL	Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation
SN60WF IOL	AcrySof Natural IQ (SN60WF) IOL	AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation

Primary Outcome Measures

Name	Time	Method
Total ocular high-order aberrations	Month 1 postoperative

Trial Locations

Locations (1)

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