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

NCT ID: NCT01105585

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

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.

Detailed Description

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Conditions

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Cataracts

Keywords

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Cataracts aspheric IOL ocular aberrations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL

Intervention Type DEVICE

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.

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

Group Type ACTIVE_COMPARATOR

AcrySof Natural IQ (SN60WF) IOL

Intervention Type DEVICE

AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

Interventions

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Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL

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.

Intervention Type DEVICE

AcrySof Natural IQ (SN60WF) IOL

AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

Intervention Type DEVICE

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;

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;
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M-09-003

Identifier Type: -

Identifier Source: org_study_id