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Completed

NCT Number: NCT01351233

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wenzhou Medical College

Wenzhou, Zhejiang, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sphere more than -6.0D;
  • Cornea astigmatism from -1.0 D to -4.0D;
  • Clinical diagnosis of complicated cataract;
  • Ask for and accept refractive lens exchange surgery;
  • Accept AcrySof Toric intraocular lens .

Exclusion criteria

  • 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;
  • Previous corneal or intraocular surgery;
  • Refuse surgery;
  • Refuse to use AcrySof Toric intraocular lens .

Treatment and study plan

cataract surgery

Procedure

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

Other names: refractive lens exchange surgery

Primary outcomes

  1. The position of IOL

    Time frame: 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 outcomes

  1. refraction astigmatism

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2011
Registry last updated
Jul 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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