Visual Function After Implantation of AcrySof® Toric Lens | NCT01074606

Studies
Visual Function After Implantation of AcrySof® Toric Lens

NCT01074606

Sponsor

Alcon Research

Status

Terminated

Last Update Posted

Sep 19, 2012Estimated

Enrollment

56Actual

Phase

Phase 4

Conditions

Cataract

Interventions

AcrySof Toric Intraocular Lens

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated based on a business decision.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Not provided

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Toric	Experimental	AcrySof Toric Intraocular Lens (IOL)	Device: AcrySof Toric Intraocular Lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AcrySof Toric Intraocular Lens	Device	Implantation of the AcrySof Toric Intraocular Lens (IOL)	Toric

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Refractive Cylinder		Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases