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
  Purpose

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.


Condition Intervention
Cataract
Procedure: Cataract Surgery

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • 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 .


Secondary Outcome Measures:
  • refraction astigmatism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    We would like to evaluate the improvement of refraction astigmatism after surgery.


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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 .

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01351233

Locations
China, Zhejiang
Wenzhou Medical College
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Study Director: Ayong Yu, Ph.D. Wenzhou Medical University
  More Information

No publications provided

Responsible Party: A-Yong Yu, Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China., Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01351233     History of Changes
Other Study ID Numbers: WMC
Study First Received: May 6, 2011
Last Updated: July 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Wenzhou Medical University:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014