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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01351233

Enrollment

Registered

2011-05-10

Start date

2011-03-31

Completion date

2012-05-31

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract

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.

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 .

Interventions

PROCEDURECataract Surgery

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026