Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects|
- 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 .
- refraction astigmatism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]We would like to evaluate the improvement of refraction astigmatism after surgery.
|Study Start Date:||March 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Procedure: Cataract Surgery
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351233
|Wenzhou Medical College|
|Wenzhou, Zhejiang, China|
|Study Director:||Ayong Yu, Ph.D.||Wenzhou Medical University|