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Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)

This study has been withdrawn prior to enrollment.
(Product availability)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878839
First Posted: April 9, 2009
Last Update Posted: August 2, 2012
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 (Responsible Party):
Alcon Research
  Purpose
A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.

Condition Intervention
Cataracts Astigmatism Device: Toric

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Aberration [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Visual acuity, residual refractive cylinder, lens alignment [ Time Frame: 3 months ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Toric
AcrySof Toric IOL to assess corneal aberration
Device: Toric
AcrySof Toric IOL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operable cataracts;
  • Good ocular health;
  • Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)

Exclusion Criteria:

  • >2.06 D astigmatism at corneal plane;
  • irregular astigmatism;
  • prior or ongoing corneal disease or scarring;
  • history of ocular disease
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00878839     History of Changes
Other Study ID Numbers: M09-016
First Submitted: April 7, 2009
First Posted: April 9, 2009
Last Update Posted: August 2, 2012
Last Verified: June 2012

Keywords provided by Alcon Research:
Cataract
Toric IOL
Corneal Aberration
Astigmatism
AcrySof

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