NCT01045733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

January 8, 2010

Last Update Submit

November 27, 2012

Conditions

CataractAstigmatism

Keywords

CataractToricIOLAcrySofLRIAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Corneal Aberration

    Month 6 postoperative

Secondary Outcomes (2)

  • Visual Acuity

    Month 6 postoperative

  • Corneal Cylinder

    6 months

Study Arms (2)

IQ Toric IOL

EXPERIMENTAL

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

IQ Aspheric IOL + LRI

ACTIVE COMPARATOR

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 IOLProcedure: Limbal Relaxing Incision (LRI)

Interventions

AcrySof IQ Toric IOLDEVICE

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.

Also known as: AcrySof IQ Toric IOL Model SN6AT3, AcrySof IQ Toric IOL Model SN6AT4, AcrySof IQ Toric IOL Model SN6AT5
IQ Toric IOL
AcrySof IQ Aspheric IOLDEVICE

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.

Also known as: AcrySof IQ Aspheric IOL Model SN60WF
IQ Aspheric IOL + LRI
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.

IQ Aspheric IOL + LRI

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

US(1)