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An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation

NCT ID: NCT01190631

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).

Detailed Description

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Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.

Conditions

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Cataracts

Keywords

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intraocular lens cataracts total residual spherical aberration high order aberrations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Acrysof IQ (SN60WF) IOL

AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery.

Group Type EXPERIMENTAL

Acrysof IQ (SN60WF) IOL

Intervention Type DEVICE

Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.

Interventions

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Acrysof IQ (SN60WF) IOL

Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.

Intervention Type DEVICE

Other Intervention Names

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Acrysof® IQ Model SN60WF

Eligibility Criteria

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Inclusion Criteria

* Age-related cataract grade 3 or lower in at least one eye;
* Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
* Able to have an operation within 30 days of preoperative evaluation;
* Good ocular health, with the exception of cataracts;
* ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
* Willing and able to understand and sign an informed consent;
* Willing and able to attend postoperative examinations per protocol schedule;
* Able to achieve 6.5mm dilated pupil;

Exclusion Criteria

* Preoperative ocular pathology as specified in protocol;
* Preoperative corneal pathology as specified in protocol;
* Keratometric astigmatism exceeding 1.50 diopter;
* Planned postoperative refraction for mono-vision;
* Uncontrolled diabetes;
* Use of any systemic or topical drug known to interfere with visual performance;
* Contact lens use during the active treatment portion of the trial;
* Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
* Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
* Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 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-10-008

Identifier Type: -

Identifier Source: org_study_id