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CompletedNCT01351233Updated Jul 6, 2012

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

An interventional study of Cataract Surgery in Cataract, sponsored by Wenzhou Medical University. Completed at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-06.

Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Cataract

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Keywords

  • Cataract
03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 1,171 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • ProcedureCataract Surgery

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

    Also known as: refractive lens exchange surgery

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 6 months

Secondary outcomes

  1. refraction astigmatism

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

    Time frame: 6 months

07

Study locations

1 site
  • Wenzhou Medical College
    Wenzhou, Zhejiang, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2011
First posted
May 10, 2011
Start
Mar 2011
Primary completionActual
May 2012
CompletionActual
May 2012
Last update
Jul 6, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01351233
Lead sponsor
Wenzhou Medical University
Responsible party
A-Yong Yu (Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China., Wenzhou Medical University) — Principal investigator
First posted
May 10, 2011
Start date
Mar 2011
Primary completion
May 2012
Completion
May 2012
Last update
Jul 6, 2012

Study contacts

Ayong Yu, Ph.D.
study director · Wenzhou Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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