Skip to main content
OpenTrials
Completed

NCT Number: NCT01045733

A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)

The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Ocular criteria must be met in both eyes.

  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend postoperative examinations per protocol schedule;
  • Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
  • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
  • Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
  • Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Previous corneal surgery;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Ocular disease and/or condition that may compromise study results;
  • Pregnant or planning pregnancy during course of study;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AcrySof IQ Toric IOL

Device

AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.

Other names: AcrySof IQ Toric IOL Model SN6AT3, AcrySof IQ Toric IOL Model SN6AT4, AcrySof IQ Toric IOL Model SN6AT5

AcrySof IQ Aspheric IOL

Device

AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.

Other names: AcrySof IQ Aspheric IOL Model SN60WF

Limbal Relaxing Incision (LRI)

Procedure

An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.

Primary outcomes

  1. Corneal Aberration

    Time frame: Month 6 postoperative

Secondary outcomes

  1. Visual Acuity

    Time frame: Month 6 postoperative

  2. Corneal Cylinder

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2010
Registry last updated
Nov 29, 2012

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.

Related clinical trials

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