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: October 16, 2012
Last verified: October 2012
  Purpose

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 Phase
Cataract
Device: Toric T3 - T9
Device: IQ SN60WF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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:
  • Uncorrected Distance Visual Acuity [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • Subject satisfaction [ Time Frame: 3 months afer surgery ] [ Designated as safety issue: No ]
    Subject satisfaction as measured by subject questionnaire


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toric T3 - T9
AcrySof IQ Toric Intraocular Lens (IOL) models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
Device: Toric T3 - T9
Bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) (models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9) following cataract removal.
Active Comparator: IQ SN60WF
AcrySof IQ Intraocular Lens (IOL) model SN60WF.
Device: IQ SN60WF
Bilateral implantation of the monofocal intraocular lens (IOL) (AcrySof IQ IOL Model SN60WF) following cataract removal.

  Eligibility

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

Inclusion Criteria:

  • Have preoperative corneal astigmatism of >=0.75 Diopter (D) as determined by IOL Master keratometry;
  • are willing and able to understand and sign an informed consent;
  • are more than 21 years of age, of either gender and any race;
  • have age related cataracts that require extraction followed by implantation of a posterior chamber intraocular lens (IOL) and used as an on-label procedure;
  • are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies;
  • have regular, bowtie shaped corneal astigmatism;
  • both eyes qualify for a Toric IOL according to the AcrySof IQ Toric Calculator (www.acrysoftoriccalculator.com);
  • are able to obtain pupil dilation >=5.0 mm.

Exclusion Criteria:

  • previous corneal surgery;
  • corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
  • concurrent corneal disease or a disruption of the ocular epithelial surface of the eye;
  • planned multiple procedures during cataract/IOL implantation surgery;
  • an ocular disease and/or condition that may compromise study results (mild blepharitis does not automatically exclude the subject);
  • an ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrollment;
  • pregnant or planning pregnancy during course of study; and
  • participated in any other investigational study within 30 days prior to enrollment.
  Contacts and Locations
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
Last Updated: October 16, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by Alcon Research:
Intraocular Lens
Toric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013