Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects

Study Overview
=================
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 .

Official Title
-----------------
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Cataract Surgery


Participation Criteria
=================
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 .

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cataract Surgery|Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refraction astigmatism | We would like to evaluate the improvement of refraction astigmatism after surgery. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract