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

Tracking Information
First Received Date ^ICMJE	August 7, 2008
Last Updated Date	March 25, 2010
Start Date ^ICMJE	June 2007
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2010)	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).
Original Primary Outcome Measures ^ICMJE (submitted: August 8, 2008)	Visual Acuity, Residual Refractive Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00732030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 25, 2010)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: August 8, 2008)	Patient Satisfaction Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low Cylinder Toric
Official Title ^ICMJE	Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
Brief Summary	Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cataracts
Intervention ^ICMJE	Device: Toric IOL (SN60T3) Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
Study Arm (s)	Experimental: AcrySof Toric T3 Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) Intervention: Device: Toric IOL (SN60T3)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	26
Completion Date	Not Provided
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosed with Cataracts Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) Exclusion Criteria: Preoperative ocular pathology Planned monovision
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00732030
Other Study ID Numbers ^ICMJE	M07-005
Has Data Monitoring Committee	No
Responsible Party	Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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