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Rotational Stability of the AcrySof® Toric

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ClinicalTrials.gov Identifier: NCT00762216
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : May 10, 2010
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataract
Intervention Device: AcrySof® Toric intraocular lens
Enrollment 71
Recruitment Details 79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements
Pre-assignment Details non-randomized
Arm/Group Title Toric
Hide Arm/Group Description Implantation with the AcrySof® Toric intraocular lens
Period Title: Overall Study
Started 71
Completed 71
Not Completed 0
Arm/Group Title Toric
Hide Arm/Group Description Implantation with the AcrySof® Toric intraocular lens
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
  53.5%
>=65 years
33
  46.5%
[1]
Measure Description: Age data collected for 69 participants; not provided for 2 participants.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
33
  46.5%
Male
38
  53.5%
[1]
Measure Description: Gender data collected for 69 participants; not provided for 2 participants.
1.Primary Outcome
Title Rotational Stability
Hide Description Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Time Frame 6 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.
Arm/Group Title Toric
Hide Arm/Group Description:
Implantation with the AcrySof® Toric intraocular lens
Overall Number of Participants Analyzed 67
Mean (Standard Error)
Unit of Measure: degrees
4  (3)
2.Secondary Outcome
Title Residual Refractive Cylinder
Hide Description The refractive astigmatism 6 months post-surgery, measured in diopters.
Time Frame 6 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.
Arm/Group Title Toric
Hide Arm/Group Description:
Implantation with the AcrySof® Toric intraocular lens
Overall Number of Participants Analyzed 69
Mean (Standard Error)
Unit of Measure: diopters
0.4  (0.4)
Time Frame [Not Specified]
Adverse Event Reporting Description No adverse events were reported for the 71 patients participating in the study.
 
Arm/Group Title Toric
Hide Arm/Group Description Implantation with the AcrySof® Toric intraocular lens
All-Cause Mortality
Toric
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Toric
Affected / at Risk (%)
Total   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Toric
Affected / at Risk (%)
Total   0/71 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888.451.3937; 817.568.6725
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00762216     History of Changes
Other Study ID Numbers: RM-08-001
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: April 14, 2010
Results First Posted: May 10, 2010
Last Update Posted: October 31, 2012