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Clinical Trials/NCT01351233
NCT01351233
Completed
Not Applicable

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

Wenzhou Medical University1 site in 1 country30 target enrollmentMarch 2011
ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Wenzhou Medical University
Enrollment
30
Locations
1
Primary Endpoint
The position of IOL
Status
Completed
Last Updated
13 years ago

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 .

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
May 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

A-Yong Yu

Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China.

Wenzhou Medical University

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 .

Outcomes

Primary Outcomes

The position of IOL

Time Frame: 6 months

Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ,We would calculate the rotation of IOL .

Secondary Outcomes

  • refraction astigmatism(6 months)

Study Sites (1)

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