- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00761488
Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
May 8, 2015 updated by: Alcon Research
To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.
Study Overview
Study Type
Interventional
Phase
- Phase 4
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
-
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Texas
-
Fort Worth, Texas, United States, 76134
- Alcon Call Center
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-
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
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.
Exclusion Criteria:
- Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
AcrySof® Toric IOL
|
Implanted into the study eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal astigmatism; IOL rotation
Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
|
Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)
Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
|
Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (Estimate)
September 29, 2008
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 8, 2015
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HK-Toric-YIU-01
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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