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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014