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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045733
• Other study ID #: M-09-045
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: November 27, 2012
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• AcrySof IQ Toric IOL
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.
• AcrySof IQ Aspheric IOL
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.

Procedure:
• Limbal Relaxing Incision (LRI)
An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Aberration		Month 6 postoperative	No
Secondary	Visual Acuity		Month 6 postoperative	No
Secondary	Corneal Cylinder		6 months	No