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

June 30, 2006
December 20, 2012
June 2005
January 2009   (final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: at each visit up to 24 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00348205
369
No
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