NCT01074606

Brief Summary

The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

September 19, 2012

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

February 23, 2010

Last Update Submit

September 18, 2012

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

  • Postoperative Refractive Cylinder

    Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative

Secondary Outcomes (2)

  • Uncorrected distance visual acuity (UCDVA)

    Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative

  • Best corrected distance visual acuity (BDCVA)

    Pre-operative, 1 month postoperative, 3 months postoperative

Study Arms (1)

Toric

EXPERIMENTAL

AcrySof Toric Intraocular Lens (IOL)

Device: AcrySof Toric Intraocular Lens

Interventions

AcrySof Toric Intraocular LensDEVICE

Implantation of the AcrySof Toric Intraocular Lens (IOL)

Toric

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
  • Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
  • All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
  • For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

You may not qualify if:

  • Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
  • AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Last Updated

September 19, 2012

Record last verified: 2011-08

Locations

TW(1)