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Rotational Stability of the AcrySof® Toric

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ClinicalTrials.gov Identifier: NCT00762216
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : May 10, 2010
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof® Toric intraocular lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotational Stability of the AcrySof® Toric
Study Start Date : May 2008
Actual Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Toric
Implantation with the AcrySof® Toric intraocular lens
Device: AcrySof® Toric intraocular lens
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery



Primary Outcome Measures :
  1. Rotational Stability [ Time Frame: 6 Months post-surgery ]
    Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.


Secondary Outcome Measures :
  1. Residual Refractive Cylinder [ Time Frame: 6 Months post-surgery ]
    The refractive astigmatism 6 months post-surgery, measured in diopters.



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

Inclusion Criteria:

  • Monolateral or bilateral cataracts
  • anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
  • 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
  • able to sign the informed consent, to comply with scheduled visits and other study procedures

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
  • uncontrolled diabetes

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): NCT00762216


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00762216     History of Changes
Other Study ID Numbers: RM-08-001
First Posted: September 30, 2008    Key Record Dates
Results First Posted: May 10, 2010
Last Update Posted: October 31, 2012
Last Verified: May 2010

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases