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Low Cylinder Toric

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.
ClinicalTrials.gov Identifier: NCT00732030
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : April 7, 2010
Last Update Posted : April 7, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).

Condition or disease Intervention/treatment Phase
Cataracts Device: Toric IOL (SN60T3) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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)
Study Start Date : June 2007
Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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).

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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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 Posted: August 11, 2008    Key Record Dates
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