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

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ClinicalTrials.gov Identifier: NCT00878839
Recruitment Status : Withdrawn (Product availability)
First Posted : April 9, 2009
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.

Condition or disease Intervention/treatment Phase
Cataracts Astigmatism Device: Toric Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Toric
AcrySof Toric IOL to assess corneal aberration
Device: Toric
AcrySof Toric IOL



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

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


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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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00878839     History of Changes
Other Study ID Numbers: M09-016
First Posted: April 9, 2009    Key Record Dates
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