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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00761488
First received: September 25, 2008
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  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: 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 astigmatism; IOL rotation [ Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Arms Assigned Interventions
Experimental: 1
AcrySof® Toric IOL
 Device: AcrySof® Toric IOL
Implanted into the study eye

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761488

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

No publications provided

Responsible Party: Ricky Ho, RA Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00761488     History of Changes
Other Study ID Numbers: HK-Toric-YIU-01
Study First Received: September 25, 2008
Last Updated: January 22, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013