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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01045733
First received: January 8, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention
Cataract
Astigmatism
Device: AcrySof IQ Toric IOL
Device: AcrySof IQ Aspheric IOL
Procedure: Limbal Relaxing Incision (LRI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Aberration [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ]
  • Corneal Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045733

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01045733     History of Changes
Other Study ID Numbers: M-09-045
Study First Received: January 8, 2010
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Cataract
Toric
IOL
AcrySof
LRI
Astigmatism

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on September 18, 2014