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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Cataract

Keywords

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Cataract Surgery

Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.

Intervention Type PROCEDURE

Other Intervention Names

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refractive lens exchange surgery

Eligibility Criteria

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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 .

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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A-Yong Yu

Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayong Yu, Ph.D.

Role: STUDY_DIRECTOR

Wenzhou Medical University

Locations

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Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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WMC

Identifier Type: -

Identifier Source: org_study_id