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Visual Function After Implantation of AcrySof® Toric Lens

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ClinicalTrials.gov Identifier: NCT01074606
Recruitment Status : Terminated (The study was terminated based on a business decision.)
First Posted : February 24, 2010
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof Toric Intraocular Lens Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Toric
AcrySof Toric Intraocular Lens (IOL)
 Device: AcrySof Toric Intraocular Lens
Implantation of the AcrySof Toric Intraocular Lens (IOL)


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Refractive Cylinder [ Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative ]

Secondary Outcome Measures :
  1. Uncorrected distance visual acuity (UCDVA) [ Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative ]
  2. Best corrected distance visual acuity (BDCVA) [ Time Frame: Pre-operative, 1 month postoperative, 3 months postoperative ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
  • Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
  • All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
  • For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
  • AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Contacts and Locations
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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): NCT01074606


Locations
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Taiwan
Changhua City, Taiwan, 500
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01074606    
Other Study ID Numbers: MT-0902
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: August 2011
Keywords provided by Alcon Research:
Cataract
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases