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AcrySof Toric Clinical Results

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01214863
First received: August 7, 2008
Last updated: September 27, 2012
Last verified: October 2010
History of Changes
  Purpose

This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.


Condition Intervention Phase
Cataracts
Astigmatism
 Device: T3
Device: T4
Device: T5
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Results With the AcrySof Toric Intraocular Lens (IOL)

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 1 day to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative refractive cylinder [ Time Frame: 1day to 6 months ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: August 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
T3
Model SN60T3 assigned by AcrySof Toric calculator
 Device: T3
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3
T4
Model SN60T4 assigned by AcrySof Toric calculator
 Device: T4
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4
T5
Model SN60T5 assigned by AcrySof Toric calculator
 Device: T5
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)

Criteria

Inclusion Criteria:

  • Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator

Exclusion Criteria:

  • Ocular comorbidities affecting visual outcome data,
  • Prior refractive surgery,
  • Irregular astigmatism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214863

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01214863     History of Changes
Other Study ID Numbers: M07-007
Study First Received: August 7, 2008
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Toric Intraocular Lens (IOL)

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on June 18, 2013