A Study to Evaluate the Safety and Effectiveness of the 2... | NCT00347997

Studies
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

NCT00347997

Sponsor

Bausch & Lomb Incorporated

Status

Withdrawn

Last Update Posted

Dec 8, 2011Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Myopia
Astigmatism

Interventions

217z Laser

Countries

Not provided

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

Dec 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision made by B&L to cancel the study, no subjects enrolled.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

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

Dec 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

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

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

Not Applicable

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
LASIK	Experimental	LASIK correction of myopia and myopic astigmatism	Device: 217z Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
217z Laser	Device	LASIK correction of myopia and myopic astigmatism	LASIK

Measure	Description	Time Frame
Visual acuity		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopia with or without astigmatism.

Exclusion Criteria:

Contraindications to LASIK.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D009216	Myopia
D001251	Astigmatism