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A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01225926
First received: October 20, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.


Condition Intervention
Cataract
Device: Toric T3 - T9
Device: IQ SN60WF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.


Enrollment: 24
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toric T3 - T9
AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
Device: Toric T3 - T9
Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
Other Name: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
Active Comparator: IQ SN60WF
AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
Device: IQ SN60WF
Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient
Other Name: AcrySof® IQ IOL Model SN60WF

  Eligibility

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

Inclusion Criteria:

  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend post-operative examinations per protocol schedule;
  • In good ocular health, with the exception of cataracts;
  • Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
  • Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
  • In good ocular health, with the exception of cataracts;
  • Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Previous corneal surgery;
  • Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Ocular disease and/or condition that may compromise study results;
  • Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
  • Pregnant or planning pregnancy during course of study;
  • Participation in any other investigational study within 30 days prior to enrolment;
  • 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01225926     History of Changes
Other Study ID Numbers: M10-003
Study First Received: October 20, 2010
Results First Received: July 22, 2013
Last Updated: September 24, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Alcon Research:
Intraocular Lens
Toric

ClinicalTrials.gov processed this record on November 25, 2014