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Low Cylinder Toric

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00732030
First received: August 7, 2008
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  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: 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Distance Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Residual Refractive Cylinder at month 6 measured in diopters (D).


Secondary Outcome Measures:
  • Patient Satisfaction Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732030

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: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00732030     History of Changes
Other Study ID Numbers: M07-005
Study First Received: August 7, 2008
Results First Received: April 29, 2009
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Toric IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013