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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00878839
First received: April 7, 2009
Last updated: July 31, 2012
Last verified: June 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Aberration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity, residual refractive cylinder, lens alignment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00878839     History of Changes
Other Study ID Numbers: M09-016
Study First Received: April 7, 2009
Last Updated: July 31, 2012
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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

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

ClinicalTrials.gov processed this record on May 21, 2013