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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01045733
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Astigmatism	Device: AcrySof IQ Toric IOL; Device: AcrySof IQ Aspheric IOL; Procedure: Limbal Relaxing Incision (LRI)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IQ Toric IOL AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.	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.; Other Names: AcrySof IQ Toric IOL Model SN6AT3 AcrySof IQ Toric IOL Model SN6AT4 AcrySof IQ Toric IOL Model SN6AT5
Active Comparator: IQ Aspheric IOL + LRI AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation	Device: 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.; Other Names: AcrySof IQ Aspheric IOL Model SN60WF ; 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.

Outcome Measures

Primary Outcome Measures

1. Corneal Aberration [Month 6 postoperative]

Secondary Outcome Measures

1. Visual Acuity [Month 6 postoperative]

2. Corneal Cylinder [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01045733
• Other Study ID Numbers: M-09-045
• First Posted: Jan 11, 2010
• Last Update Posted: Nov 29, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Alcon Research: Cataract; Toric; IOL; AcrySof; LRI; Astigmatism
• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Nov 29, 2012