NCT01351233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

May 6, 2011

Last Update Submit

July 4, 2012

Conditions

Cataract

Keywords

Cataract

Outcome Measures

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 .

    6 months

Secondary Outcomes (1)

  • refraction astigmatism

    6 months

Interventions

Cataract SurgeryPROCEDURE

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

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ayong Yu, Ph.D.

    Wenzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China.

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 10, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

CN(1)