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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01351233
First received: May 6, 2011
Last updated: July 4, 2012
Last verified: July 2012

May 6, 2011
July 4, 2012
March 2011
May 2012   (final data collection date for primary outcome measure)
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 .
Same as current
Complete list of historical versions of study NCT01351233 on ClinicalTrials.gov Archive Site
refraction astigmatism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
We would like to evaluate the improvement of refraction astigmatism after surgery.
Same as current
Not Provided
Not Provided
 
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
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.

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 .

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cataract
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Sphere more than -6.0D;
  2. Cornea astigmatism from -1.0 D to -4.0D;
  3. Clinical diagnosis of complicated cataract;
  4. Ask for and accept refractive lens exchange surgery;
  5. Accept AcrySof Toric intraocular lens .

Exclusion Criteria:

  1. 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;
  2. Previous corneal or intraocular surgery;
  3. Refuse surgery;
  4. Refuse to use AcrySof Toric intraocular lens .
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01351233
WMC
Yes
A-Yong Yu, Wenzhou Medical College
Wenzhou Medical University
Not Provided
Study Director: Ayong Yu, Ph.D. Wenzhou Medical University
Wenzhou Medical University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP