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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:
ClinicalTrials.gov Identifier:
NCT01351233
First Posted: May 10, 2011
Last Update Posted: July 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical College
  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
Intervention Model: Single Group Assignment
Masking: None (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 A-Yong Yu, Wenzhou Medical College:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • refraction astigmatism [ Time Frame: 6 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 6, 2011
First Posted: May 10, 2011
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by A-Yong Yu, Wenzhou Medical College:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases