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 Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Cataract 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 .

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The position of IOL	Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ，We would calculate the rotation of IOL .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
refraction astigmatism	We would like to evaluate the improvement of refraction astigmatism after surgery.	6 months

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Study Director: Ayong Yu, Ph.D., Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 4, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: WMC