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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01045733

Enrollment

Registered

2010-01-11

Start date

2009-12-31

Completion date

2011-05-31

Last updated

2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract

Keywords

Cataract, Toric, IOL, AcrySof, LRI, Astigmatism

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.

Interventions

DEVICEAcrySof 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.

DEVICEAcrySof 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.

PROCEDURELimbal 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Corneal Aberration	Month 6 postoperative

Secondary

Measure	Time frame
Visual Acuity	Month 6 postoperative
Corneal Cylinder	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026