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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00

Conditions
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Cataracts

Intervention / Treatment
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* Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL
* Device: AcrySof Natural IQ (SN60WF) IOL


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 21 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZCB00 IOL<br>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 | Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL<br>* Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.<br>|
| Active Comparator: SN60WF IOL<br>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 | Device: AcrySof Natural IQ (SN60WF) IOL<br>* AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ocular high-order aberrations |  | Month 1 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataracts, aspheric, IOL, ocular aberrations