Low Cylinder Toric
This study has been completed.
Information provided by:
First received: August 7, 2008
Last updated: March 25, 2010
Last verified: March 2010
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
|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:
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.
|Study Start Date:||June 2007|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
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