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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
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bilateral Cataract
Intervention Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  40.0%
>=65 years
9
  60.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
12
  80.0%
Male
3
  20.0%
1.Primary Outcome
Title Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Hide Description 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.
Time Frame Before Surgery and 180 days after second eye implant
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description:
ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Before Surgery 11
After Surgery 2
2.Primary Outcome
Title Reduction of Cylinder
Hide Description 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.
Time Frame 6 months after surgery on second eye
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects were included in this analysis.
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description:
ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Overall Number of Participants Analyzed 15
Mean (95% Confidence Interval)
Unit of Measure: Percent reduction of cylinder
85.67
(77.04 to 94.30)
3.Primary Outcome
Title Lens Axis Misalignment
Hide Description 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.
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects were included in this analysis.
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description:
ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: Degrees
0.3
(0 to 2)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Toric Intraocular Lens
Hide Arm/Group Description ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
All-Cause Mortality
Toric Intraocular Lens
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Toric Intraocular Lens
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Eye disorders   
Secondary Surgical Intervention  [1]  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
One subject underwent a secondary surgical intervention (IOL repositioning) in the first eye to resolve refractive error due to inaccurate pre-operative manual keratometry.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Toric Intraocular Lens
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Per clinical protocol confidentiality/study publication specifications all data discoveries arising out of the study, patentable of nonpatentable, shall be the sole property of Alcon Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888-451-3937; 817-568-6725
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00967473     History of Changes
Other Study ID Numbers: C-08-062
First Submitted: August 25, 2009
First Posted: August 27, 2009
Results First Submitted: June 23, 2011
Results First Posted: July 22, 2011
Last Update Posted: January 9, 2017