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This study has been withdrawn prior to enrollment.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
  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:


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
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, see Learn About Clinical Studies.

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 August 20, 2014