Back to resultsEvaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
About this trial
This is an interventional health services research trial for Cataract focused on measuring Cataract
Eligibility Criteria
Inclusion Criteria:
- Sphere more than -6.0D;
- Cornea astigmatism from -1.0 D to -4.0D;
- Clinical diagnosis of complicated cataract;
- Ask for and accept refractive lens exchange surgery;
- Accept AcrySof Toric intraocular lens .
Exclusion Criteria:
- Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
- Previous corneal or intraocular surgery;
- Refuse surgery;
- Refuse to use AcrySof Toric intraocular lens .
Sites / Locations
- Wenzhou Medical College
Outcomes
Primary Outcome Measures
The position of IOL
Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ，We would calculate the rotation of IOL .
Secondary Outcome Measures
refraction astigmatism
We would like to evaluate the improvement of refraction astigmatism after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01351233
Brief Title
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Official Title
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Other Intervention Name(s)
refractive lens exchange surgery
Intervention Description
Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.
Primary Outcome Measure Information:
Title
The position of IOL
Description
Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ，We would calculate the rotation of IOL .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
refraction astigmatism
Description
We would like to evaluate the improvement of refraction astigmatism after surgery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sphere more than -6.0D;
Cornea astigmatism from -1.0 D to -4.0D;
Clinical diagnosis of complicated cataract;
Ask for and accept refractive lens exchange surgery;
Accept AcrySof Toric intraocular lens .
Exclusion Criteria:
Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
Previous corneal or intraocular surgery;
Refuse surgery;
Refuse to use AcrySof Toric intraocular lens .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayong Yu, Ph.D.
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
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