Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2011 | ||||
| Last Updated Date | July 4, 2012 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The position of IOL [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ,We would calculate the rotation of IOL . |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01351233 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
refraction astigmatism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] We would like to evaluate the improvement of refraction astigmatism after surgery. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects | ||||
| Official Title ICMJE | Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects | ||||
| Brief Summary | The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric intraocular lens in the bag in high myopic subjects. |
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| Detailed Description | According to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (D) of refractive astigmatism. New toric IOL designs (Acrysof © toric IOL; Alcon), approved by the US Food and Drug Administration (FDA) at the end of 2005, have been found to be more stable and safety in the capsular bag in subjects with normal axis length of eye. Then,this study aims at the confirmation of the stability of The AcrySof Toric intraocular lens in the bag in high myopic subjects.Then we may find a more effective treatment for the high myopic patients with complicated cataract and sever cornea astigmatism . |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Cataract | ||||
| Intervention ICMJE | Procedure: Cataract Surgery
Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.
Other Name: refractive lens exchange surgery |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01351233 | ||||
| Other Study ID Numbers ICMJE | WMC | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | A-Yong Yu, Wenzhou Medical College | ||||
| Study Sponsor ICMJE | Wenzhou Medical College | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wenzhou Medical College | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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