A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00348205

First received: June 30, 2006

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2006
Last Updated Date	December 20, 2012
Start Date ^ICMJE	June 2005
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2009)	Visual Acuity [ Time Frame: at each visit up to 24 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00348205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2009)	Safety [ Time Frame: at each visit up to 24 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Official Title ^ICMJE	Not Provided
Brief Summary	A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hyperopia Astigmatism
Intervention ^ICMJE	Device: Technolas 217z Zyoptix Laser Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Study Arm (s)	Experimental: Technolas 217z Zyoptix System Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Intervention: Device: Technolas 217z Zyoptix Laser
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	97
Completion Date	March 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Hyperopia with or without astigmatism. Exclusion Criteria: Contraindications to LASIK.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00348205
Other Study ID Numbers ^ICMJE	369
Has Data Monitoring Committee	No
Responsible Party	Bausch & Lomb Incorporated
Study Sponsor ^ICMJE	Bausch & Lomb Incorporated
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bausch & Lomb Incorporated
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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