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Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric

This study has been withdrawn prior to enrollment.
(Primary Investigator resigned from hospital)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761488
First Posted: September 29, 2008
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.

Condition Intervention Phase
Cataract Device: AcrySof® Toric IOL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal astigmatism; IOL rotation [ Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. ]

Secondary Outcome Measures:
  • Uncorrected and best distance corrected visual acuities (UCVA and BDCVA) [ Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
AcrySof® Toric IOL
Device: AcrySof® Toric IOL
Implanted into the study eye

  Eligibility

Information from the National Library of Medicine

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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:

  • 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

Exclusion Criteria:

  • Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
  Contacts and Locations
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): NCT00761488


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

Responsible Party: Ricky Ho, RA Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00761488     History of Changes
Other Study ID Numbers: HK-Toric-YIU-01
First Submitted: September 25, 2008
First Posted: September 29, 2008
Last Update Posted: May 12, 2015
Last Verified: January 2010

Keywords provided by Alcon Research:
Visual acuity,
corneal and
refractive
cylinder
following
implantation of the
AcrySof® Toric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases