Comparison of Corneal Aberrations and Visual Outcomes in... | NCT00929747

Studies
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients

NCT00929747

Sponsor

Alcon Research

Status

Withdrawn

Last Update Posted

Apr 12, 2012Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Cataracts

Interventions

Toric
Limbal Relaxing Incision

Countries

United States

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Management Decision

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 25, 2009

First Submission Date that Met QC Criteria

Jun 26, 2009

First Posted Date

Jun 29, 2009Estimated

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

Apr 10, 2012

Last Update Posted Date

Apr 12, 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

A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Toric IOL	Active Comparator	AcrySof IQ Toric IOL	Device: Toric
Limbal Relaxing Incision	Active Comparator	AcrySof IQ with Limbal Relaxing Incision	Procedure: Limbal Relaxing Incision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toric	Device	Unilateral implantation of the AcrySof IQ Toric IOL	Toric IOL

Measure	Description	Time Frame
Corneal aberration		3 months

Measure	Description	Time Frame
Visual acuity		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

operable cataracts
good ocular health
0.5 D to 2.0 D of corneal astigmatism

Exclusion Criteria:

> 2.0 D astigmatism
irregular astigmatism
prior or ongoing corneal disease or scarring
history of ocular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided