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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351233
• Other study ID #: WMC
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: July 4, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Cataract Surgery
Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	refraction astigmatism	We would like to evaluate the improvement of refraction astigmatism after surgery.	6 months	Yes