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Low Cylinder Toric

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732030
First Posted: August 11, 2008
Last Update Posted: April 7, 2010
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
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).

Condition Intervention Phase
Cataracts Device: Toric IOL (SN60T3) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Distance Visual Acuity [ Time Frame: 6 months ]
    Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

  • Best Corrected Distance Visual Acuity [ Time Frame: 6 Months ]
    Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

  • Residual Refractive Cylinder [ Time Frame: 6 Month ]
    Residual Refractive Cylinder at month 6 measured in diopters (D).


Secondary Outcome Measures:
  • Patient Satisfaction Survey [ Time Frame: 6 months ]
    Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.


Enrollment: 26
Study Start Date: June 2007
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AcrySof Toric T3
Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL)
Device: Toric IOL (SN60T3)
Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Cataracts
  • Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)

Exclusion Criteria:

  • Preoperative ocular pathology
  • Planned monovision
  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): NCT00732030


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

Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00732030     History of Changes
Other Study ID Numbers: M07-005
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: April 29, 2009
Results First Posted: April 7, 2010
Last Update Posted: April 7, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
Toric IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases