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Visual Function After Bilateral Implantation of AcrySof® Toric

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758550
First Posted: September 25, 2008
Last Update Posted: March 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Condition Intervention Phase
Visual Function Device: AcrySof® Toric IOL Device: AcrySof Natural Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function After Bilateral Implantation of AcrySof® Toric

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Visual Acuity (UCVA) [ Time Frame: 6 Months after surgery ]
    Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


Secondary Outcome Measures:
  • Questionnaire Results [ Time Frame: 6 Months ]
    Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).


Enrollment: 60
Study Start Date: April 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Active Comparator: AcrySof Natural IOL
AcrySof Natural Intraocular Lens (IOL)
Device: AcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral cataracts
  • 40~80 years of age
  • 4 Days - 1 Week interval between a single patient's surgery
  • dilated pupil size (in dim light) ≥ 4.0 mm
  • Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
  • 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion Criteria:

  • Preoperative ocular pathology
  • Previous intraocular or corneal surgery
  • An increased risk for complications which could require vitreoretinal surgery
  • Corneal irregularities
  • Corneal opacities
  • Current contact lens usage(within 6 months prior to first surgery)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758550


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

Responsible Party: Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00758550     History of Changes
Other Study ID Numbers: CM-06-17
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: August 13, 2009
Results First Posted: March 16, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
Visual function;
Refractive cylinder;
AcrySof® Toric;
AcrySof® Natural