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

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01351233
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Cataract Surgery	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• 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
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Outcome Measures

Primary Outcome Measures

1. The position of IOL [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

1. refraction astigmatism [6 months]

   We would like to evaluate the improvement of refraction astigmatism after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Wenzhou Medical College	Wenzhou	Zhejiang	China

Sponsors and Collaborators

• Wenzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A-Yong Yu, Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China., Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT01351233
• Other Study ID Numbers: WMC
• First Posted: May 10, 2011
• Last Update Posted: Jul 6, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by A-Yong Yu, Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China., Wenzhou Medical University: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jul 6, 2012