Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Cylinder Toric

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: NCT00732030
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : April 7, 2010
Last Update Posted : April 7, 2010
Sponsor:
Information provided by:
Alcon Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataracts
Intervention Device: Toric IOL (SN60T3)
Enrollment 26
Recruitment Details Patients were >21 years of age, of any race and either gender. Patients had operable cataracts in at least 1 eye and were able to provide informed consent. Patients were free of systemic diseases affecting ocular health and had a predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) by the AcrySof Toric calculator.
Pre-assignment Details During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled.
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description Each enrolled eye receives AcrySof Toric SN60T3 IOL
Period Title: Overall Study
Started 26
Completed 24
Not Completed 2
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  26.9%
>=65 years
19
  73.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
16
  61.5%
Male
10
  38.5%
1.Primary Outcome
Title Uncorrected Distance Visual Acuity
Hide Description 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).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected for 29 eyes in 24 patients.
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description:
Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: logMAR
0.09  (0.14)
2.Primary Outcome
Title Best Corrected Distance Visual Acuity
Hide Description 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).
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected for 29 eyes in 24 patients.
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description:
Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: logMAR
0.02  (0.09)
3.Primary Outcome
Title Residual Refractive Cylinder
Hide Description Residual Refractive Cylinder at month 6 measured in diopters (D).
Time Frame 6 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description:
Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: Diopters
0.4  (0.4)
4.Secondary Outcome
Title Patient Satisfaction Survey
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description:
Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Daytime Distance Vision 4.6  (0.6)
Nighttime Distance Vision 4.4  (0.7)
Indoors Distance Vision 4.6  (0.7)
Time Frame Surgical visit through 6 month postoperative visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AcrySof Toric T3
Hide Arm/Group Description Each enrolled eye receives AcrySof Toric SN60T3 IOL
All-Cause Mortality
AcrySof Toric T3
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AcrySof Toric T3
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AcrySof Toric T3
Affected / at Risk (%)
Total   0/24 (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.
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
Results Point of Contact
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888.451.3937; 817.568.6725
Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00732030     History of Changes
Other Study ID Numbers: M07-005
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: April 29, 2009
Results First Posted: April 7, 2010
Last Update Posted: April 7, 2010