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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348205
First Posted: July 4, 2006
Last Update Posted: December 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
June 30, 2006
July 4, 2006
December 28, 2012
June 2005
January 2009   (Final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: at each visit up to 24 Months ]
Not Provided
Complete list of historical versions of study NCT00348205 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: at each visit up to 24 months ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Not Provided
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hyperopia
  • Astigmatism
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.
Experimental: Technolas 217z Zyoptix System
Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.
Intervention: Device: Technolas 217z Zyoptix Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
March 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hyperopia with or without astigmatism.

Exclusion Criteria:

  • Contraindications to LASIK.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00348205
369
No
Not Provided
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Not Provided
Bausch & Lomb Incorporated
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP