ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
|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: NCT00967473|
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : July 22, 2011
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment|
|Bilateral Cataract||Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2009|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Experimental: Toric Intraocular Lens
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8
Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye.
- Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment [ Time Frame: Before Surgery and 180 days after second eye implant ]Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
- Reduction of Cylinder [ Time Frame: 6 months after surgery on second eye ]Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
- Lens Axis Misalignment [ Time Frame: Time of surgery ]Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.
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): NCT00967473
|United States, Texas|
|Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|