A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Willing and able to understand and sign an informed consent;
Willing and able to attend post-operative examinations per protocol schedule;
In good ocular health, with the exception of cataracts;
Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
In good ocular health, with the exception of cataracts;
Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Previous corneal surgery;
Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
Planned multiple procedures during cataract/IOL implantation surgery;
Ocular disease and/or condition that may compromise study results;
Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
Pregnant or planning pregnancy during course of study;
Participation in any other investigational study within 30 days prior to enrolment;
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Toric T3 - T9

Device

Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient

Other names: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9

IQ SN60WF

Device

Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Other names: AcrySof® IQ IOL Model SN60WF

Primary outcomes

Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3

Time frame: Month 3

Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 21, 2010
Registry last updated: Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed