- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214863
AcrySof Toric Clinical Results
September 27, 2012 updated by: Alcon Research
Clinical Results With the AcrySof Toric Intraocular Lens (IOL)
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
144
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76134
- Alcon Call Center for Trial Locations
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)
Description
Inclusion Criteria:
- Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator
Exclusion Criteria:
- Ocular comorbidities affecting visual outcome data,
- Prior refractive surgery,
- Irregular astigmatism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
T3
Model SN60T3 assigned by AcrySof Toric calculator
|
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3
|
|
T4
Model SN60T4 assigned by AcrySof Toric calculator
|
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4
|
|
T5
Model SN60T5 assigned by AcrySof Toric calculator
|
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Acuity
Time Frame: 1 day to 6 months
|
1 day to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative refractive cylinder
Time Frame: 1day to 6 months
|
1day to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 5, 2010
Study Record Updates
Last Update Posted (Estimate)
October 1, 2012
Last Update Submitted That Met QC Criteria
September 27, 2012
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M07-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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